Pharmaceuticals 4th leading cause of death.
April 17, 2005
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.
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
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.
For its part, the FDA generally demands only that new drugs work - not that
they work better than existing ones. Dr. Janet Woodcock, an FDA deputy
commissioner, says off-label prescribing and allowing similar drugs for the
same condition present more options - and "choice is important."
Many safety experts say more new drugs should be tested against marketed
ones, with more safety data required and stronger control of consumer ads
and off-label promotion.
For now, though, most Americans seem to feel like Heckman: "grateful that
there's a pill to take for something."
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
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