Clarification to This Article
The article incorrectly said that a generic formulation of the heart attack drug Plavix is available. In August 2006, Apotex, a Canadian pharmaceutical company, briefly sold a generic version of the drug, also known as clopidogrel. Plavix's maker, a joint venture of Sanofi Aventis and Bristol-Myers Squibb, got a court injunction prohibiting further importation. In some parts of the United States, however, generic clopidogrel continued to be available for as long as a year. The supply is now exhausted. Generic versions of the drug, unapproved by the Food and Drug Administration, can be bought over the Internet. Those drugs can be seized or refused entry by the government.
A Case of Getting What You Pay For
With Heart Attack Treatments, as Quality Rises, So Does Cost

By David Brown
Washington Post Staff Writer
Sunday, July 26, 2009

Two decades ago, a famous clinical experiment showed that if a patient in the throes of a heart attack chewed and swallowed an aspirin tablet, the risk of dying fell from 13.2 percent to 10.2 percent.

If progress since then had come so cheap and easy -- a 23 percent improvement for an investment of three cents -- health care in the United States wouldn't be in the state it is.

But that's not how things happened.

Instead, the fight against heart disease has been slow and incremental. It's also been extremely expensive and wildly successful.

In the 1960s, the chance of dying in the days immediately after a heart attack was 30 to 40 percent. In 1975, it was 27 percent. In 1984, it was 19 percent. In 1994, it was about 10 percent. Today, it's about 6 percent.

Over the same period, the charges for treating a heart attack marched steadily upward, from about $5,700 in 1977 to $54,400 in 2007 (without adjusting for inflation).

The treatment of coronary heart disease -- of which heart attack, or acute myocardial infarction, is the most significant component -- this year will cost about $93 billion. It's a huge contributor to the $2.3 trillion annual bill for medical care in the United States. Cardiovascular disease is responsible for 35 percent of deaths in America and has been the leading cause of death every year since 1900, except 1918, the year of the Spanish flu epidemic.

The evolution of heart attack treatment over the past three decades is a story of doing more things to more people at greater expense with better results. It is a portrait in miniature of medicine in the United States.

Although inappropriate care, high administrative costs, inflated prices and fraud all add to the country's gigantic medical bill, the biggest driver of the upward curve of health spending has been the discovery of new and better things to do when someone gets sick.

"Money matters in health care as it does in few other industries," wrote Harvard University health economist David Cutler in 2004. "Where we have spent a lot, we have received a lot in return."

Beyond heart attack treatment, similar stories can be told about cancer, premature birth, arthritis, HIV infection, mental illness and innumerable other common conditions. The trend in all of them toward more intensive, expensive and better treatment is not likely to change with health-care reform, however constituted.

Providing health insurance to the 47 million Americans who don't have it -- the key feature of the bills before Congress -- is likely to expand heart attack treatment and increase spending on it, not pare it back and reduce the cost.

The revolution in heart attack care has occurred over the working careers of cardiologists who aren't even very old.

"When I was in medical school, about all we had to offer was oxygen, morphine and prayers," said Eric Topol, director of the Scripps Translational Science Institute in La Jolla, Calif.

Topol, who turned 55 last month, graduated from medical school in 1979. For 15 years he was head of cardiology at the Cleveland Clinic, where he helped run some of the clinical trials that have changed treatment so dramatically.

Today, someone having a heart attack who gets to a hospital in time is likely to get cardiac catheterization, angioplasty, the placement of a medicated stent, therapy with four anticoagulant drugs and, on discharge, a handful of lifetime prescriptions.

"There's been a complete transformation in how it's handled just since I've been in medicine," Topol said.

That transformation has saved the lives of millions of Americans.

In 1970, the death rate from coronary heart disease was 448 per 100,000 people. In 1980, it was 345. In 1990, it was 250. In 2000, it was 187. In 2006, it was 135 -- less than a third of what it was during Topol's senior year of high school.

About half the decline since 1980 is a consequence of better medical care, and about half is the result of a more favorable "risk profile" for Americans -- less smoking, lower cholesterol, better blood pressure.

To understand the step-wise change in complexity, outcome and cost of treatment, it's useful to understand what a heart attack is and how it threatens life.

"Myocardium" means "muscle of the heart," and "infarction" is from the Latin verb meaning "to plug up." A myocardial infarction occurs when an artery delivering oxygen-rich blood to the beating heart muscle is suddenly narrowed or blocked, usually by a blood clot forming on a cholesterol-encrusted blood vessel wall.

If the situation persists, the muscle tissue suffocates and dies. The result is a permanently and sometimes fatally weakened heart and a susceptibility to abnormal rhythms. The goal of treatment is to unplug the artery and stop any arrhythmia. The second task proved easier to address than the first.

The first coronary care unit was opened in the United States in 1962. It let physicians continuously monitor the heart rhythms of heart attack patients and shock them out of the most dangerous one, called ventricular fibrillation. Researchers estimate that between 1968 and 1976, the spread of such units across the country accounted for a 14 percent decline in mortality from heart attacks.

By the mid-1980s, cardiologists knew that if people who survived a heart attack took a heart-calming drug called a beta blocker after they were discharged from the hospital, the chance that they would die in the next year fell by about 25 percent. It was a huge -- and economical -- development, as the drugs were very cheap.

But the biggest breakthrough came in 1988 with the Second International Study of Infarct Survival.

That huge clinical trial -- involving more than 17,000 patients in 417 hospitals -- showed that aspirin, which slows the clotting of blood, decreased mortality by nearly one-quarter when taken during a heart attack. Streptokinase, an intravenous medicine that dissolves clots, conferred roughly the same benefit.

When a patient took both drugs, the chance of dying fell from 13.2 percent to 7.2 percent -- an achievement that astonished the world of cardiology.

Soon another clot-dissolving drug, called TPA, came on the market. It cost $1,200 compared with $300 for streptokinase. The new question was: Is TPA worth it? By 1994, the conclusion was: Yes.

Several studies showed that TPA shaved mortality by 1 percent (to 6.3 percent) compared with streptokinase. The cost of treating a heart attack went up another notch.

The next important issue involved angioplasty, in which a plastic catheter is snaked into the blocked artery and a small balloon is inflated, opening the vessel. The procedure had been around for more than a decade, but cardiologists weren't certain when to use it.

The conclusion of two dozen trials in the 1990s: Use it a lot more.

An angioplasty costs more than 10 times the price of a dose of TPA. In 1993, American cardiologists performed 375,000 angioplasties. In 2000, they did 676,000, according to data prepared by Anne Elixhauser, a biostatistician at the federal Agency for Healthcare Research and Quality.

The number inched up further after 2002, when a study showed that it was worth doing angioplasties even if a hospital didn't have heart surgeons on hand to rescue patients from the occasional catastrophic complication.

That opened smaller, community hospitals to the procedure. In 2007, U.S. cardiologists did 721,000 of them.

Clinical trials in the 1990s also showed that if a wire-mesh tube -- a stent -- was put into the blocked artery, there was less chance that the vessel would close up. Stents didn't change heart attack survival significantly, but they became standard practice nevertheless, adding to the bill.

In recent years, researchers have sought to learn whether stents impregnated with an anti-inflammatory compound perform better than bare metal ones. The answer appears to be: Yes, a little.

Bare metal stents cost $600 to $800 apiece, while "drug-eluting" ones go for $1,500 to $2,200. About 70 percent of angioplasties use the more expensive ones. The benefit, though, is very small. People who get a $1,500 stent have a 5 percent lower risk of needing a whole new procedure than people who get a $600 one.

And then there's the $300 to $900 dose of GPIIb/IIIa inhibitor (another blood thinner) given at the time of the procedure, and out of the hospital a year of clopidogrel (Plavix) and a lifetime of statin, ACE inhibitors, beta blockers and aspirin.

It is safe to say that almost everybody who has a heart attack wants the best treatment available. Nobody wants to turn back the clock.

"No part of health reform is talking about rationing who gets this care and improvement in treatment," said Cutler, the Harvard economist, who is one of President Obama's principal advisers on health care.

Would requiring more people to have health insurance bring lifesaving treatment to a lot more heart attack patients?

One assumes that most people with crushing chest pain don't worry about insurance coverage before calling an ambulance. A study published in 2007 found that people without insurance had higher rates of stroke and death -- but not of heart attack -- than people with insurance. Universal coverage, in itself, may not change much.

At the same time, prices for some elements of state-of-the-art care are coming down. Statins, ACE inhibitors and Plavix are all available in generic formulations. A couple of years ago, Medicare reduced what it pays for angioplasties.

Experience, however, suggests that treating heart attacks is very unlikely to get cheaper in the future -- either for individual patients or for the country as a whole.

"The low-hanging fruit has been largely consumed," said C. Michael Gibson, a cardiologist and chief of clinical research at Beth Israel Deaconess Medical Center in Boston. "We are now facing the battle of a half- to one percent improvements in mortality that will come at very high cost."

A big focus in cardiology right now is to get more heart attack victims to the hospital. Today, about 40 percent of them delay longer than six hours, by which time optimal treatment isn't possible.

If that effort is successful, even more Americans will be able to experience the revolution in cardiac care in the past three decades.

The bill will go up, too.

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