Experts warn on health...

Experts warn on health, wealth expense of U.S. drugs

PLYMOUTH, Mass. (AP) — About 130 million Americans swallow, inject, inhale, infuse, spray, and pat on prescribed medication every month, the U.S. Centers for Disease Control and Prevention indicates. Americans buy much more medicine per person than any other country.

The number of prescriptions has swelled by two-thirds over the past decade to 3.5 billion yearly, according to IMS Health, a pharmaceutical consulting company. Americans devour even more nonprescription drugs, polling suggests.

Recently, safety questions have beset some depression and anti-inflammatory drugs, pushing pain relievers Vioxx and — most recently — Bextra from the market. Rising ranks of doctors, researchers and public health experts are saying that America is overmedicating itself. It is buying and taking far too much medicine, too readily and carelessly, for its own health and wealth, they say.

U.S. drug costs v. other nations UNITED STATES Private insurance pays for much of the cost of prescription drugs, and publicly funded Medicaid covers many poor people. Drug companies may advertise directly to consumers but must portray both benefits and risks. The Food and Drug Administration sometimes requests follow-up safety studies after approving a drug for marketing, but it has limited powers to force completion of such research. The FDA can force a drug from the market but often encourages a drug company to act voluntarily. CANADA Medicines are purchased through a variety of public and private health plans. Government price controls keep prices low, making the market attractive to many cross-border American buyers. Consumer advertising is tightly regulated, with many forms banned outright. The federal government can demand safety studies after a drug is approved and pull it off the market if they show a problem. BRITAIN The government heavily subsidizes prescription medication, typically picking up all but $12 per prescription. Some get free prescriptions, like the elderly, children, the disabled, and people on welfare. Prescription contraceptives are free to all. However, any medicine not on a government list must be bought at full cost to the consumer. Drug companies may advertise to consumers, but the content is strictly regulated. Regulators keep track of adverse drug reactions and investigate worrisome patterns. They can ask a company to do further tests, suspend the license, or order a withdrawal. SWEDEN All medicines are sold retail through a state corporation, and the government also heavily subsidizes the cost of prescriptions. Under a recent directive, a prescribed drug that qualifies for a subsidy should be exchanged for the cheapest comparable generic. Direct-to-consumer advertising is banned. Marketing permission must be renewed every five years, and some new medicines are given only conditional approval that requires follow-up studies. JAPAN National Health Insurance typically picks up two-thirds of drug costs. Companies may not advertise prescription drugs to consumers but can advertise over-the-counter drugs. The law allows large-scale imports of unapproved drugs in an emergency, such as an epidemic. After initial approval, new drugs are subject to a six-year probation, then re-evaluated for safety and effectiveness. Source: The Associated Press

Well over 125,000 Americans die from drug reactions and mistakes each year, according to Associated Press projections from landmark medical studies of the 1990s. That could make pharmaceuticals the fourth-leading national cause of death after heart disease, cancer and stroke.

The pharmaceutical industry served up more than $250 billion worth of sales last year, the vast majority in prescriptions, according to industry consultants. That roughly equaled sales at all the country's gasoline stations put together, or an $850 pharmaceutical fill-up for every American.

Alice and Ken Heckman each begin their morning by cracking open a rattling plastic tray carting scores of pills in a rainbow of pastel colors.

Between the two of them, they gulp 29 pills every day: a regimen of 14 drugs, with a chaser of dietary supplements.

Here's the curious part: They feel pretty hale for people in their early 70s, working around the house and volunteering with several community groups. They each had heart fixes years ago — him a bypass and her a vessel-clearing stent — but fully recovered. She has well-controlled diabetes. He has worked his way through heartburn, arthritis, an enlarged prostate and occasional mild depression.

Do we need all these drugs? A relative handful yank many people away from almost certain death, like some antibiotics and AIDS medicines. Though carrying some risk, other drugs — such as cholesterol-cutting statins — help a considerable minority dodge potential calamities like heart attack or stroke.

The right balance of risk and benefit is still harder to strike for a raft of heavily promoted drugs that treat common, persistent, daily life conditions: like anti-inflammatories, antacids, and pills for allergy, depression, shyness, premenstrual crankiness, waning sexual powers, impulsiveness in children — you name it.

"We are taking way too many drugs for dubious or exaggerated ailments," says Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of "The Truth About the Drug Companies."

"What the drug companies are doing now is promoting drugs for long-term use to essentially healthy people. Why? Because it's the biggest market."

In fact, relatively few pharmaceutical newcomers greatly improve the health of patients over older drugs or advance the march of medicine. Last year, the U.S. Food and Drug Administration classified about three-quarters of newly approved drugs as similar to existing ones.

Confronted with mounting costs, drug makers churn out and promote uninspired sequels like Hollywood: drugs with the same ingredients in a different form for a different disease.

Of course, many pharmaceuticals improve American health. "We now have more medicines and better medicines for more diseases," says Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America.

However, the nation also overindulges far too often, the critics say, and violates the classic proscription of the ancient Greek physician Hippocrates: "First, do no harm."

Drug safety researcher Dr. James Kaye, of Boston University, remembers a medical school teacher telling the class: "All drugs are poisonous!"

The Heckmans found out on their own. Heckman lost his alertness for several months to a depression medication. His wife has come down with a rash from one heart medicine and muscle aches from a statin. But each time they switched medicines and escaped any lingering harm.

Hospital patients suffer seven hard-to-foresee adverse drug reactions and another three outright drug mistakes for every 100 admissions, estimates Dr. David Bates, a researcher at Boston's Brigham and Women's Hospital. That translates into 3.6 million drug misadventures a year.

The dangers potentially escalate when doctors prescribe drugs, as they often do, for uses not formally approved by the FDA. In a recent report, the Centers for Disease Control voiced concern about huge off-label growth of antidepressants. They have expanded to treat often loosely defined syndromes of compulsion, panic or anxiety and PMS.

Drug makers, doctors and patients have all been quick to medicate some conditions once accepted simply as part of the human condition.

Many Americans also assume, often with a nod from sellers or doctors, that new drugs inevitably work better than old ones. "Newer isn't always better, and more isn't always better," warns Dr. Donald Berwick, an adviser to the U.S. Agency for Healthcare Research and Quality.

The Heckmans buy both new and old — nearly $9,000 worth of prescriptions a year, plus hundreds of dollars in cheaper over-the-counter medicines. Even with supplemental insurance, their monthly out-of-pocket share of prescriptions alone roughly equals their food bills.

Around the country, prescription drug sales have pushed relentlessly upward by an annual average of 11% over the past five years.

The aging population is partly at fault, with its attendant ailments like cancer, heart attacks, stroke and Alzheimer's disease. Other conditions have mysteriously proliferated, including asthma, diabetes and obesity.

Exercise and better diet ward off heart disease and diabetes just as effectively as drugs do, studies show. However, says Fred Eckel, who teaches pharmacy practice at the University of North Carolina, "There tends to be a reliance on drugs as the first option."

Drug advertising to consumers has also boomed since the late 1990s, thanks largely to relaxed government restrictions on television spots.