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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 even necessary to report
one. That 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 emergency 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 to the consumer's medicine cabinet, we're 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 full-time 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 fen-phen
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 error-plagued system. For example, studies show that
one in 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 they 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 that 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 be an expert to grasp how many lives we could
save, and injuries we might prevent, with even a modest investment
in drug safety. SOURCE: Reprinted from the 5 April, 1998, issue of the Los Angeles Times, Orange County Edition. Reprinted in the public service of the national interest of the American people. |
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