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The Dollars in Heart Research

Where does the money come from and how does it pave the way for research? Melissa Mares covers heart health funding.

By MELISSA MARES
Drs. C. Walton Lillehei and F. John Lewis performed the world’s first open-heart surgery in September of 1952. The patient was a 5-year-old girl who had been born with a hole in her heart. Doctors cooled the girl’s body to 81 degrees Fahrenheit and opened her chest to sew the hole in her heart closed. The procedure had to be finished in less than 10 minutes, because the technology that keeps blood pumping during heart surgery had not been developed yet (putting the patient into a hypothermic state slowed the heart enough to allow doctors to operate without bypassing the heart). With the hole repaired, doctors warmed the patient back to her normal 98.6 degree Fahrenheit body temperature. The girl survived and the surgery was deemed a success.
    Fifty-six years later, doctors no longer need to use hypothermia or rush through a procedure in 10 minutes in order to keep their patients alive during surgery.  In fact, doctors often do not even always need to open a patient’s chest to fix the heart. This particular area of cardiology has made “explosive progress” in the last 3 to 5 years, says Dr. Ted Feldman, director of cardiac catheterization at Evanston Northwestern Healthcare (ENH).
  
Cardiology’s advancements since that first surgery are a result of painstaking research and long-term development of new devices, technology and procedures for treating cardiac problems. That research costs tens of millions of dollars per year. On top of that, the costs associated with health care for a population in which cardiovascular disease is the number one killer of many groups continue to rise.
     According to the National Heart, Lung and Blood Institute, coronary heart disease’s estimated direct and indirect costs this year in the United States will be $156.4 billion.  Costs associated with stroke, hypertensive disease and heart failure make up another $169.7 billion.
    In contrast, funding from the health industry (including drug companies and others) for cardiovascular research is $8 billion per year. Government funding, through the National Institutes of Health (NIH), amounts to approximately $2 billion annually. And as costs rise, the already-wide gap between the cost of research and the funding available for it will continue to widen.
    The American Heart Association (AHA) dedicates approximately $150 million per year to research, almost one-third of the organization’s total funding. The AHA is the largest source of funding for research after the NIH and industry. The organization raises money through solicitation of individual donors, fundraising events and networking among potential corporate donors.
    Much of the money the AHA raises goes toward grant applications that the association wants to fund, according to Dr. Robert Bonow. Bonow, who served as president of the AHA from 2002 to 2003, is the Goldberg Distinguished Professor at Northwestern University's Feinberg School of Medicine and chief of the division of cardiology at Northwestern Memorial Hospital.
    Even if a research project gets grant money or successfully raises capital, those involved still face a long road in terms of maintaining funding and getting the product or procedure to the point of approval by the Food and Drug Administration (FDA).
    As an interventional cardiologist with ENH, Feldman develops less invasive alternatives to open-heart surgery, which often involve less risk of infection or other complications than open-heart surgery.
    This progress is driven by doctors and entrepreneurs who establish start-up companies to develop devices and procedures that will eventually be approved by the FDA. These start-ups are expensive to start and run, though, as they require a research team, patent lawyers, engineers, other staff and several phases of animal and human trials to achieve FDA approval for the product.
    For instance, Feldman is part of a team developing a non-surgical method of repairing leaking mitral heart valves. While the idea for this treatment first came about in 1991, the team is still in trials today.
    After establishing a company to drive the research and development of the technique, the team completed animal trials, then a Phase I trial with 55 human patients. Presently, the team is halfway through Phase II human trials, which are on target to finish in 2008. Then there is at least one year of patient follow-up and another year for the FDA approval process. It will be 2010 before the procedure is potentially approved, Feldman says, making the time spent on this project from the initial idea to (projected) approval 19 years.
    If the FDA approves a procedure or device, developers can apply to Medicare and ask them to cover it for treatment of patients the same way Medicare would for the traditional treatment protocol. Private insurers will sometimes follow Medicare’s lead, which helps pay for the patients’ treatment. Sometimes private insurers, or Medicare, don’t agree to take part, though, putting even more strain on a researcher's finances.
    Feldman says that these start-ups are extremely under-funded and become more so as overhead goes up and funding goes down. Bonow also emphasized this point.
    “Scientists are in major competition for funds,” Bonow says. The NIH’s budget is falling, as well, which makes the field even more competitive, he adds.
    At this point, doctors and developers turn to donors for support. Some of these donors have benefited in some way from the treatment, says Feldman. Hospital fundraising does not address these needs usually, Feldman says, and those funds often go toward facilities and education instead of research.
    Additional funding sometimes comes from sales of a device or procedure overseas, where the approval process can be shorter and technology can be sold sooner.
   One of the AHA’s fundraising and awareness-promoting efforts is called Go Red for Women, a movement aimed at fighting heart disease, the top killer of American women.
    Amy Huntington is president and CEO of Juno Lighting Group and co-chair of the 2008 Go Red for Women luncheon, to be held on February 29 in the Walnut Room at Macy’s State Street. This year’s luncheon aims to have 600 women attend to raise $650,000. Last year’s goal for the luncheon was $450,000.
    The movement has engaged 14,000 companies, and the response has been positive, Huntington says.
    “[The cause] resonates no matter who you’re talking to,” Huntington says.
    The research and efforts to raise awareness about heart disease has begun to pay off, according to Huntington. She says that Juno has always emphasized healthy lifestyles for company employees by sponsoring Go Red for Women, offsetting portions of health club membership fees and encouraging employees to take part in provided smoking cessation programs.
    Through the Go Red for Women initiative, Huntington also works to get female leadership of other companies engaged with the AHA, and she says that other companies are realizing that these initiatives in the workplace help to cut sick days and health care costs.
    “One major shift is that it’s not just health care companies that are interested in heart health,” Huntington says. “Corporate America is getting it….Our employees can live longer, stronger lives.”
    Bonow agrees that the public is increasingly aware of the dangers of heart disease and its risk factors. In turn, more researchers are attracted to studying this area.
    “Scientists are trying to find an area to make an impact in,” Bonow says. The AHA is putting more money into stroke research, as well as research into long-term and short-term outcomes for patients with heart disease.
    Huntington says the impact of Go Red for Women has been extraordinary because although cardiovascular disease has gotten more attention recently, the public still does not realize the full extent of the danger it represents. “This is the leading cause of death among women,” Huntington says. “Many women don’t know that.” o

For more information:
•Go Red for Women:  www.goredforwomen.org
•American Heart Association:  www.americanheart.org
•National Heart, Lung and Blood Institute: www.nhlbi.nih.gov
•Evanston Northwestern Healthcare cardiology information, including links to information on Dr. Feldman's work: www.enh.org/clinicalservices/cardiology

Published: February 07, 2008
Issue: February 08 Money Issue