The Heart of the Matter: Actions and Solutions Needed for Biggest Health Burden

Every 38 seconds, someone in the United States dies from a cardiovascular-related event. By some accounts, roughly half of adults in the United States have risk factors for cardiovascular disease. Nearly every one of us has been or will be touched by CVD in some way in our lifetimes.

Despite the enormity of the problem in the United States and tremendous progress combatting other diseases, we’re losing the battle against CVD. Following decades of decline, the mortality rate from CVD disease has increased over the past 10 years.

Cardiovascular-related mortalities are the leading cause of death in the United States, eclipsing deaths from all forms of cancer combined. Debilitating conditions from CVD are pervasive, including the long-term effects of heart attacks and strokes. CV-related impacts from obesity and diabetes are adding to this enormous public health challenge.

These collective burdens weigh heavily on our families, communities and health care system. Consider this: $1 of every $6 in health care is spent on CV disease; hospitalization costs for a heart attack are double those of an average hospital stay; and a heart attack or stroke can place severe ongoing financial burdens on patients and families and result in a major loss of productivity that makes it difficult for them to ever get back on their feet. Patients and families deal with diminished quality of life, loss of income, increased emotional stress, additional hospitalizations and numerous other challenges.

In a nation known for astounding medical and scientific innovation, how did this happen, and what can we do about it?

It’s been 30 years since statin therapy was first introduced. Once statins were proven effective in addressing a portion (25-35 percent) of the risk associated with CVD, society lost its sense of urgency in reducing the remaining, significant CVD-related risks.

The dialogue quieted. Researchers, public health experts and companies shifted attention to other disease areas. Innovation and investment slowed and, eventually, so did our progress in reducing CVD.

In the void left behind, millions of Americans now take earlier-generation products, such as niacin and fenofibrates or omega-3 dietary supplements — all of which have failed in outcomes studies to deliver cardiovascular benefit on top of proven therapies, and none of which are recommended by the Food and Drug Administration for treatment of CV disease.

We need renewed focus and action. On our current course, the American Heart Association estimates that the cost of treating CV disease will exceed $1 trillion by 2035. Three key initiatives are critical to reversing this trend, saving lives and reducing the tremendous burden on families and our economy:

— Making CV risk reduction a national health priority, with an increased focus on education;

— Vigorously and fearlessly pursuing research to find new ways to preventatively reduce risk;

— Providing pricing leadership that makes affordable solutions broadly available to those in need.

A national priority: CV risk reduction

First, cardiovascular risk reduction must regain its place in the forefront of our national health dialogue. We must redouble our efforts to stop our biggest killer. Millions of Americans face an ongoing (often unknown) threat of a heart attack, stroke or CV death, even though they’re on a statin, with well-controlled cholesterol levels. We all need to be educated about the risks of CV disease, the importance of proper diet and exercise and the limitations of existing medical therapies and dietary supplements.

The imperative of research

Second, we must vigorously and fearlessly pursue research to find more innovative ways to reduce persistent CV risk, with an emphasis on preventative care and outcomes-based results. Amarin committed a decade ago to investing in CV research and development when many others abandoned the field. At a cost of more than $300 million, we funded a landmark clinical study (REDUCE-IT) examining persistent CV risk and the impact of icosapent ethyl (VASCEPA) in reducing risk of major cardiovascular events in combination with statins. (The results of this trial are currently under review by the FDA.)

In the past five years, Amarin has sponsored more than 100 scientific papers and presentations. These efforts have helped spark a re-examination of treatment guidelines by leading medical associations for the management of CV risks.

Pricing leadership

Third, there is an opportunity to lead the way in responsible pricing. New, innovative solutions are crucial to reducing persistent CV risk for millions of Americans, but they also need to be affordable and covered by insurance plans.

A major U.S. third-party drug-pricing watchdog group recently concluded that Amarin’s product is cost-effective for the CV risk reduction indication we are pursuing. In addition, there is a growing body of pharmacoeconomic data that affirms its value. We believe that Amarin’s affordable pricing of its drug will encourage broad coverage by medical insurance, thereby making it available to all who can benefit.

Turning the tide of complacency and rising CV risks and deaths is possible. More than 30 years after the introduction of statins in 1987, we have an opportunity to favorably bend the curve again. If we commit to action, we can reignite a national dialogue, spur new research and responsibly bring cost-effective solutions to the millions of Americans whose lives depend on it.


John Thero is president and CEO of Amarin.

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