PRESCRIPTION DRUGS: DANGER WITHIN THE CURE

Imagine a war on crime in which nobody knew how many murders occurred, or a
Federal Aviation Administration that was unaware of how many airplanes had
crashed. Suppose we were so casual about fatal automobile accidents that it
was not necessary to report one.

This is how we monitor the risks of prescription drugs, though they account
for more deaths each year than all murders, auto accidents and airplane
crashes combined. It is estimated that more than 100,000 people die every
year from the adverse effects of prescription drugs, and 1 million are
injured so severely they require hospitalization. Many of these deaths and
serious injuries could be prevented with better programs and policies to
limit the dangers involved.

Many people take pills confident the Food and Drug Administration has
ensured that only safe drugs reach consumers. While the FDA has a generally
competent and dedicated staff, this is not what happens. The FDA's job is
to make sure each new drug is tested thoroughly enough to identify its
risks, and provide substantial evidence that it has medical benefits.

This means approved drugs usually have their benefits celebrated in the
growing flood of direct-to-consumer advertising. But they also have major
risks that are inadequately monitored, often ignored by doctors and seldom
understood by consumers. The leading painkillers frequently cause
perforated ulcers, requiring emergencey surgery and resulting in 70,000
hospitalizations a year. Digoxin, a best-selling heart drug, caused more
than 200,000 hospitalizations over a seven-year period. Even the awesome
power of antibiotics carries risks that must be managed. They can create
conditions in which intractable intestinal infections flourish or trigger a
life-threatening allergic reaction. Millions more are afflicted with
moderate side effects, including rashes, insomnia, nausea, hair loss,
depression and sexual dysfunction. Drugs are inherently risky, and from the
FDA tothe consumer's medicine cabinet,were doing a poor job minimizing
those dangers.

The problem begins at the FDA, and the priorities imposed by limited budget
and congressional mandates. For years, the chief complaint was that the FDA
was too slow to approve new drugs. When given additional funds collected
from drug companies, the FDA responded impressively. With a 40% increase
in the drug-review staff since 1993, the FDA now approves new drugs as fast
or faster than in Europe.

Unfortunately, the narrow focus on new drugs has made worse the already
inadequate safety monitoring of drugs being taken by millions of consumers.
The FDA has more than 1,500 full-time employees with duties mainly related
to evaluating new drugs. However, a fulltime staff of just 54 is
responsible for monitoring the safety of the 5,000 prescription and
over-the -counter drugs already on the market. There are more full-time
federal employees in the U.S. Naval Academy laundry (a total of 107), than
assigned to monitor the risks of drugs taken by millions of consumers.

To detect drug-related injuries and deaths, the FDA relies mainly on a
voluntary system so widely ignored by health professionals that 99% of all
adverse effects are never reported. As a result, the FDA cannot say whether
deaths and serious injuries from drugs are increasing or reliably identify
which drugs require greater vigilance in their use. As the diet-drug
debacle with fenphen proved, without better monitoring, people may continue
to be harmed for decades before the danger is identified.

We have even more serious problems in the doctor's office than at the FDA.
The medical journals are filled with research that documents in horrifying
detail an err0r-plagued system. For example, studies show that one of five
elderly are prescribed at least one drug that is inappropriate or dangerous
in an older population. Another revealed that 21% of all prescriptions for
antibiotics were inappropriately given to combat the common cold, a virus
against which these drugs are risky and ineffective. Government surveys
show that more than two of three doctors fail to tell patients anything
about the risks of the drug they just prescribed, despite a legal and
ethical obligation to do so.

Of equal concern are the alarming number of simple medication errors in
hospitals, pharmacies and doctors' offices. Common mistakes include
confusing the drug name, getting the dose wrong or ignoring the results of
a diagnostic test or a plainly documented drug allergy. Reported deaths
from medication errors, now more than 7,000 a year, have nearly tripled in
a decade's time. Yet, many fatal medication blunders undoubtedly are never
reported on death certificates.

While the nation's hospitals are now paying more attention to the
drug-safety breakdown, the doctor's office remains dangerously error prone.
Without new tools and a better system, even the most conscientious of
doctors is likely to make an unacceptable number of errors.

In such a poorly managed, inherently dangerous system, consumers must pay
far more attention to risks and benefits of the drugs they take. Can thay
recognize the adverse effects of the drugs they're taking, especially the
subtle ones like fatigue or mild depression? Is this one of the drugs where
a small overdose is dangerous? Do consumers know when they take one of the
many drugs with alarming withdrawal effects if discontinued suddenly? These
are just a few of the many questions that must be answered to use drugs
wisely.

While individuals can do much to reduce their risks, an effective solution
requires action by a concerned nation the usually does not neglect
important safety issues. For example, we spend $3 billion annually to
install air bags in new automobiles, hoping to save about 300 lives a year.
Responding to the fatal crash of a TWA airliner near New York, in which
terrorism was not involved, the federal government launched a massive
counter-terrorism effort with 200 new employees at the FAA and another
1,300 at the FBI.

Yet, with 1 million severely harmed each year by prescription drugs, the
FDA monitoring program has a budget of about $7 million. You don't have to
an expert to grasp how many lives we could save, and injuries we might
prevent, with even a modest investment in drug safety.