Report examines ROI on personalized medicine

By Anne Zieger, February 4, 2009 — Personalized medicine–which uses genetic data to provide specialized medicine for individual patients–is slowly moving into the healthcare mainstream, though only a few practical applications exist to date. However, when it does become practical, it may be a financial blessing. A new report by the Deloitte Center for Health Solutions finds that personalized medicine could provide significant ROI for all of the key stakeholders in the U.S. healthcare system.

………………………………………… — A new report by the Deloitte Center for Health Solutions finds significant opportunities for the adoption of personalized medicine to produce a positive return on investment for key stakeholders in the U.S. healthcare system. The report also finds that consumers stand to gain the most significant ROI within the shortest time period.

The report, titled “The ROI for Targeted Therapies: A Strategic Perspective,” provides an analysis of personalized medicine’s economic value proposition. It examines the importance of ROI for multiple stakeholders–consumers, diagnostic companies, pharmaceutical and biotechnology companies, and payers. A literature review of two clinical scenarios found that all stakeholder groups experienced a positive ROI under certain conditions, and that consumers consistently experienced a positive ROI across all scenarios. Payers received only a marginal benefit, and that was after six years.

The report also concludes that providers could benefit from the new tools offered by personalized medicine to improve patient care; however, reimbursement issues will need to be worked out with payers. Additionally, as providers implement electronic health records, new decision-support tools will help facilitate the adoption of disease-specific standards of practice that can provide real-time data to help prioritize therapies based on potential drug interactions and patient clinical profiles.


Assessing the barriers and incentives for adopting personalized medicine

Personalized medicine is the application of new methods of genetic analysis to diagnose, treat and manage disease – or predisposition of disease – on an individual basis. It has the power to transform health care within the foreseeable future from a population-based model to a subpopulation and individual model and is already having a disruptive impact on the U.S. health care system.

To help increase government and industry awareness of what could be one of this century’s most transformative changes in medicine, it is imperative to examine the incentives for and barriers to investing in and paying for personalized medicine.

“The ROI for Targeted Therapies: A Strategic Perspective,” a new study produced by the Deloitte Center for Health Solutions, part of Deloitte LLP, addresses the following research questions:

· Does personalized medicine have a quantifiable ROI?

· Can an economic framework be derived from case studies that will demonstrate differences in ROI across industry stakeholders?

Deloitte developed a framework for calculating personalized medicine’s ROI by examining case studies categorized by two scenarios – altering a standard course of therapy or introducing a companion therapy – across a number of clinical conditions, ranging from HIV/AIDS to breast cancer. The study calculates the ROI for four key stakeholder groups: consumers, payors, biotechnology/pharmaceutical companies and diagnostic companies.

Through the use of the two clinical scenarios, the study found that all stakeholder groups experienced a positive ROI under certain conditions, although payors received only a marginal benefit and that is after six years. Consumers stood to gain the most significant ROI opportunity within the shortest time period.

This report was released at the Personalized Medicine Coalition conference, “Achieving ROI in Personalized Medicine: Barriers, Incentives and Pathways to Successful Commercialization,” on January 27, 2009 in Washington D.C. An archived video recording of the conference will be available on this Web site soon.


There’s a scientific explanation for the heightened winter risk
A5AB3548-179B-4C7A-8294-006888F44E3A.jpg, February 3, 2009, by Rececca Ruiz — Winter can be a treacherous time for the heart, but there are ways to stay healthy.

Six inches of fluffy snow can be the perfect antidote to winter’s depressing grayness–at least until the sidewalk needs shoveling.

That’s when overzealous homeowners decide that pushing and lifting heaps of snow is a great way to catch up on months of missed visits to the gym. To make matters worse, too many of these shovelers are overweight smokers with early-stage cardiovascular disease. The result: Winter is the season with the greatest risk of heart attacks.

There’s a scientific explanation for the heightened winter risk. Cold air can cause blood vessels to constrict. Add the trigger of sudden exertion and the result can be a heart attack.

“It’s like racing an automobile with a chinking fuel line and trying to get up hill,” explains Dr. Howard Weintraub, the clinical director for New York University’s Center for the Prevention of Cardiovascular Disease. “Squeezing the fuel line will not be good.”

Protecting your most vital organ is easier than you might think. The best prevention involves a comprehensive approach. However, you can start with simple steps, such as wearing a scarf to protect against the chilly air. It’s also helpful to know how you rank on important heart disease predictors like blood pressure and cholesterol levels.

Cooling Effect
Positioned near the trachea, the heart can respond poorly to cold air entering the body through the mouth. As blood vessels constrict in response and less blood flows through the narrowed vessels, it can strain the heart. The tension only increases as the heart tries to pump more blood through a body trying to perform a demanding task.

This push-pull phenomenon likely explains why, according to a 1998 Journal of the American College of Cardiology study, more than 50% of heart attacks occur in the winter months. This wintertime peak has been confirmed by other studies, including one published in 2004 by the journal Circulation that shows that cardiac mortality is highest during December and January.

Dr. Weintraub says people should exercise caution when the temperature drops below freezing, and particularly when it dips below 20 degrees Fahrenheit.

Though exposure to air pollution is a much smaller risk factor for cardiovascular disease than obesity or smoking, Dr. William T. Abraham, chief of cardiovascular medicine at Ohio State University, says it can be an important consideration during the winter since some studies have demonstrated a link between exposure to air pollution and a hardening of the arteries and disruption of blood vessel activity.

Preventive Measures
To reduce the risk of a heart attack during the winter, begin with the most obvious step: Try breathing through the nose or covering the mouth with a scarf to warm incoming cold air. Be sure to dress warmly ,and get the body loose and limber before shoveling snow. Instead of piling on clothes, try dressing in three layers: an inner layer that wicks moisture to the surface where it can evaporate, a second layer that provides insulation and a third layer that can repel rain and water while letting moisture escape into the air. Finally, avoid exerting yourself in the extreme cold if possible.

While these are necessary preliminary steps, they won’t address your underlying risk factors, says Dr. Martha Daviglus, professor of preventive medicine at Northwestern University and a spokeswoman for the American Heart Association. These factors include diabetes, smoking, obesity, high cholesterol, high blood pressure and a sedentary lifestyle, all of which can strain the heart.

“The artery may already be full of plaque,” says Daviglus, describing the buildup of cholesterol, which narrows and hardens the artery wall. “It’s just waiting for that one thing.”

The single determining factor that causes the plaque to burst, leading to a heart attack, could be anything, including cold weather, stress or overeating.

That’s why prevention should include regular exercise, a diet rich in fruits, vegetables and whole grains and knowing your cholesterol, blood pressure and blood sugar levels.

Dave O’Brien, a 62-year-old former NFL player-turned-commercial banker, was stunned to discover that heart health can’t be taken for granted. Last May, a blood test known as PLAC that measures enzymes associated with inflammation of the arteries, helped his physician identify a blockage of his carotid artery, two large blood vessels that supply the brain with blood.

O’Brien was stunned by the diagnosis. He believed he’d been practicing good heart health by taking cholesterol-lowering statins, staying active by skiing and golfing, and avoiding fatty foods, including fried clams, a favorite dish in his native Boston.

Since the diagnosis, O’Brien has started an exercise routine and adjusted the dosage of his statins. Still, additional tests have shown that he’s likely to experience a cardiac event in the next few years.

“I just had no clue,” he says. “My doctor had no clue. The good news is that it’s at least a few years out … and I can modify my behavior to address it.”

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Warm Up

Positioned near the trachea, the heart can respond poorly to cold air entering the body through the mouth. As blood vessels constrict in response and less blood flows through the narrowed vessels, it can strain the heart. The tension only increases as the heart tries to pump more blood through a body trying to perform a demanding task. To protect your heart in chilly conditions, wear a scarf over your mouth to warm the incoming air and avoid overexertion.

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Stay Active

Exercising frequently is important to heart health year-round, but it’s particularly important during the winter, when strenuous activity can strain the heart more than usual. To achieve a moderate level of fitness, you should exercise for at least 30 minutes a day, five days a week. A high level of cardiovascular fitness requires 30 to 60 minutes of exercise at 50% to 80% of your maximum capacity most days of the week, according to the American Heart Association.


Sleep Well

Obstructive sleep apnea, a disorder resulting in inadequate breathing at night, is very common in heart disease patients. Dr. William T. Abraham, chief of cardiovascular medicine at Ohio State University, says that’s largely because untreated obstructive sleep apnea leads to decreased oxygen levels in the blood, which triggers a release of adrenaline-like hormones into the bloodstream. Over time, those stress hormones can increase your risk for cardiovascular disease.

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Eat Well

A heart-healthy diet, according to the American Heart Association, is composed of fruits, vegetables and whole grains. These foods are rich in vitamins, minerals and fiber and can help control weight and lower blood cholesterol. Replace high-fat meat with lean cuts. Eat fish, which may help lower your risk for coronary artery disease. It’s also important to reduce your intake of partially hydrogenated vegetable oils, like those found in margarine and shortening. For more information, visit the AHA.

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Know Your Risks

Lifestyle choices and genetics can lead to higher risk factors for coronary artery disease and heart attacks. Among those you can try to control are smoking, high blood cholesterol, diabetes, physical inactivity, obesity and high blood pressure. Risk also increases with age: men over 45 and women over 55 (or past menopause) are more likely to experience heart complications. The same can also be true for individuals who have a family history of early cardiovascular disease.

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Know Your Numbers

As your risk increases with age or other factors, it’s important to routinely check cholesterol, blood pressure and blood sugar levels. These three indicators can hint at troubling changes in your arteries and veins. So-called bad cholesterol can build up in the arteries and cause blockages. High blood pressure, which damages the artery walls over time, can lead to coronary heart disease. High blood sugar may confirm a diagnosis of diabetes, a major risk factor for heart disease


Get Tested

In addition to tests that determine cholesterol, blood pressure and blood sugar levels, there are also tests that reveal inflammation in the body, a potential predictor of a heart attack. A simple blood test for C-reactive protein, which is produced by the liver, can identify systemic inflammation in the body. Another blood test known as the PLAC test can measure levels of an enzyme associated with inflammation of the arteries.

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Pay Attention to Symptoms

Classic signs of a heart attack include shortness of breath, heaviness or tightness in the pectoral area, a squeezing sensation that can be localized in the shoulder and general discomfort that requires you to sit down and rest. Heart attack victims may also develop a cold sweat and become nauseated. If these symptoms are extreme or do not improve, seek attention immediately.