-Caveat Lector-
RACHEL'S ENVIRONMENT & HEALTH WEEKLY #632
---January 7, 1999---
ANOTHER KIND OF DRUG PROBLEM
A medical report in 1998 estimated that adverse reactions to
prescription drugs are killing about 106,000 Americans each year
-- roughly three times as many as are killed by automobiles.[1]
This makes prescription drugs the fourth leading killer in the
U.S., after heart disease, cancer, and stroke. The report
included only drugs that were given properly and under normal
circumstances, excluding drugs that were administered in error
or taken in attempted suicides. (When errors of administration
are included, the death toll may be as high as 140,000 per
year.[2] Such errors include prescribing the wrong drug or the
wrong dosage; giving medications to the wrong person; giving
medications to the right person but in the wrong quantities or
the wrong frequencies, and so forth.)
According to the 1998 report, which analyzed the data from 39
separate studies conducted over the last 32 years in U.S.
hospitals, 3.2 out of every 1000 (or 3200 per million) hospital
patients die from adverse reactions to prescription drugs. Of
the 106,000 people killed each year by prescription drugs in the
U.S., 41% (43,000) were admitted to the hospital because of an
adverse drug reaction; the other 59% (63,000 people) were
hospitalized for some other cause but developed a fatal reaction
to prescription drugs they received while hospitalized. In the
U.S. in 1994, there were 33,125,492 hospital admissions.
The sale of prescription drugs has more than doubled in the U.S.
during the past 8 years. In 1990, Americans spent $37.7 billion
on prescriptions; in 1997, national spending on prescriptions
reached 78.9 billion.[3] Prescription drugs are the
fastest-growing portion of health-care costs, having risen at
the rate of 17% per year for the past few years.[3]
Urging physicians to prescribe particular drugs -- especially
new drugs -- is a huge business. According to the NEW YORK
TIMES, the sales force of the largest 40 drug companies has
"exploded" in recent years.[3] In 1994, there were 35,000
full-time "detail people" employed by drug companies to visit
doctors and describe pharmaceutical products; by 1998, the
number had grown to 56,000 -- one sales person for every 11
physicians.[3] Drug companies spent $5.3 billion in the first
11 months of 1998 sending their "detail people" into doctors'
offices and hospitals, plus another $1 billion putting on
"marketing events" for doctors.
Not all adverse reactions to new drugs can be anticipated or
avoided under the present system, according to medical experts.
"It is simply not possible to identify all the adverse effects
of drugs before they are marketed," say three physicians writing
in the NEW ENGLAND JOURNAL OF MEDICINE.[4] In fact, "Overall,
51% of approved drugs have serious side effects not detected
prior to approval."[5]
Side effects from new drugs cannot be anticipated for 2 main
reasons: (1) Individuals vary greatly in their reactions to
chemical substances; and (2) drugs are tested rare side effects
may not appear in such a small group but may become painfully
obvious when millions of people start taking the drug. Even a
few years ago, drugs reached a mass audience slowly, providing
time for unexpected side effects to show up in relatively small
numbers of people. But today drugs are marketed directly to
consumers via TV, so a huge market for a new product can be
created quickly and side effects can appear in large numbers of
people. The sexual potency drug, Viagra, provides an example of
this phenomenon. Within a few months of its introduction,
several million people began taking Viagra, and many serious
side effects, including fatalities, suddenly appeared.
Despite the widespread knowledge that half of all new drugs will
cause serious side effects in some people, neither the
government nor the drug companies systematically collect
information on adverse reactions to new drugs. "Even when it is
recognized that a new drug will be given to many patients for
many years, rarely are systematic post-marketing studies carried
out."[4]
In the U.S., there is no formal procedure for monitoring drug
safety. If physicians became aware that a new drug has killed or
maimed one of their patients, or caused an allergic reaction,
they may report it but they also may not. As reports filter into
the U.S. Food and Drug Administration (FDA) in hit-or-miss
fashion, FDA can revoke the approval of a drug, and sometimes
does, but almost never quickly. In December, 1997, the popular
nonsedating antihistamine terfenadine was withdrawn from the
market because a safer alternative existed without terfenadine's
danger of a potentially fatal heart arrhythmia (irregular heart
beat). However, by that time terfenadine had been on the market
12 years. Last September the FDA took the diet drugs
fenfluramine and dexfenluramine off the market because of heart
valve damage to 31% of those who took the drugs in combination
with another diet pill, phentermine (a combination known as fen/-
phen) Fenfluramine could also damage heart valves when taken
alone. By the time fenfluramine was banned, it had been on the
market for 24 years.
A recent commentary by three doctors, published in the NEW
ENGLAND JOURNAL OF MEDICINE, contrasted prescription drug safety
with airline safety.
Airplanes are built, licensed and flown according to standards
set by the Federal Aviation Administration (FAA). But whenever a
plane crash occurs, a different agency (the National
Transportation Safety Board, or NTSB) steps in to establish the
facts and make recommendations for avoiding future crashes. The
assumption is that a second, independent agency is needed
because the FAA would have a conflict of interest investigating
crashes of planes it had approved and licensed.
In drug safety, on the other hand, there is only one agency. The
Food and Drug Administration (FDA) approves pharmaceuticals and
it also has responsibility for investigating injuries and deaths
caused by those pharmaceuticals. As we have seen, FDA has a very
limited capacity to conduct surveillance studies so, in fact,
they rely on the drug companies to provide data on deaths and
illnesses caused by their own products.
As mentioned above, the diet drug dexfenfluramine was taken off
the market in 1997 because, combined with phentermine (the fen/-
phen diet-pill combination), it damaged heart valves.[4] When
the FDA learned that dexfenfluramine was dangerous, the agency
had no good data on the total number of people harmed. At the
time, the director of FDA's Office of Epidemiology and
Biostatistics said, defensively, "We've done what is necessary
to determine there is a problem. Other information is up to
American Home Products [which marketed dexfenfluramine] to find
out." Of course American Home Products had little incentive to
investigate the number of problems caused by its product.
The three doctors comment, "Given the litigious climate
surrounding issues of drug safety, information from
investigations conducted by parties with vested interests is
unlikely to be impartial and is seldom publicly available to
improve future decision making."
The three doctors say an independent drug safety board --
analogous to the National Transportation Safety Board -- is
needed to study deaths and illnesses from drugs. They point out
that FDA officials spend up to a year of their lives evaluating
a drug before approving it for marketing "and it is unlikely
that those who recommended a drug for approval could later
conduct a dispassionate evaluation of possible harm due to that
drug."
According to a recent commentary in the JOURNAL OF THE AMERICAN
MEDICAL ASSOCIATION, a competent drug safety program would have
four parts:
(1) A program to monitor all adverse effects from prescription
drugs and annually report the number of injuries and deaths and
their likely causes. Currently no one keeps such statistics.
(2) A program to monitor side effects from new drugs. Presently,
the FDA's Division of Pharmacovigilance and Epidemiology (DPE)
has a staff of 52 people, but only 8 of those have MD degrees
and only one has a Ph.D. in epidemiology. This small group
collects anecdotal information about side effects of new drugs,
but hasn't the resources to be systematic or thorough.
The problem with anecdotal information is that only about 1% of
adverse drug reactions get reported in this way. For example,
the FDA received an average of 82 reports each year about
adverse reactions caused by the drug digoxin. This relatively
small number of reports seemed to indicate that digoxin was not
a big problem. However a systematic survey of Medicare records
revealed 202,211 hospitalizations for adverse reactions to
digoxin during a seven-year period.
When FDA's DPE identifies a drug problem, they can only pass the
information along to the division of FDA that approved the drug.
That division can require the manufacturer to develop additional
information. However, "The most common corrective action is a
change in the product disclosure label or package insert."[5] The
question then becomes, are such warnings effective?
(3) The third part of a competent drug safety program would make
sure that safety information is being disseminated and heeded by
physicians. FDA currently has no such program. "The limited
information available, however, suggests that some important
safety information--such as boxed warnings on drug disclosure
labels--either was not received or had little effect. For
example, one outcome of the protracted debate over the safety of
the sedative triazolam was a new drug label warning that it
should be prescribed for only 7 to 10 days. Several years later
an FDA task force reported that 85% of the prescriptions were
being written for longer periods.... Neither the FDA nor any
other agency has an organized program to find out whether the
important warning messages are achieving their intended purpose
of protecting the public and, if not, discovering the cause."[5]
(4) The fourth part of a competent drug safety program would
aggressively seek out information about unsuspected adverse
reactions to drugs. Instead of waiting passively for anecdotal
information to filter in, the government needs to aggressively
look for drug involvement in reported birth defects, heart
problems and other common disorders that are frequently caused
by prescription drugs. In the same way that the world's public
health specialists aggressively seek out new strains of
influenza, FDA needs to be aggressively seeking out new side
effects of drugs.
Rather than strengthening the U.S. government's drug safety
programs, the present Congress has recently diminished the
powers of the FDA to monitor drug safety. Congress now allows
drug companies to pay fees which FDA uses to speed up the
approval process for new drugs. As a result, during 1996-1997,
FDA approved 92 new drugs for market -- twice the previous rate.
However, Congress specifically prohibited FDA from using any of
the new money for monitoring drug safety.[4]
[1] Jason Lazarou and others, "Incidence of Adverse Drug
Reactions in Hospitalized Patients," JOURNAL OF THE AMERICAN
MEDICAL ASSOCIATION Vol. 279, No. 15 (April 15, 1998), pgs.
1200-1205. And see: David W. Bates, "Drugs and Adverse Drug
Reactions; How Worried Should We Be? [editorial]" JOURNAL OF THE
AMERICAN MEDICAL ASSOCIATION Vol. 279, No. 15 (April 15, 1998),
pgs. 1216-1217.
[2] David C. Classen and others, "Adverse Drug Events in
Hospitalized Patients," JOURNAL OF THE AMERICAN MEDICAL
ASSOCIATION Vol. 277, No. 4 (January 22/29, 1997), pgs. 301-306.
[3] Abigail Zuger, "Fever Pitch: Getting Doctors To Prescribe Is
Big Business," NEW YORK TIMES January 11, 1999, pgs. A1, A13.
[4] Alastair J.J. Wood and others, "Making Medicines Safer --
The Need for an Independent Drug Safety Board," NEW ENGLAND
JOURNAL OF MEDICINE Vol. 339, No. 25 (December 17, 1998), pgs.
1851-1854.
[5] Thomas J. Moore and others, "Time to Act on Drug Safety,"
JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Vol. 279, No. 19
(May 20, 1998), pgs. 1571-1573.
Descriptor terms: pharmaceutical drugs; hospitals; drug
industry; fenfluramine; dexfenfluramine; airline safety;
phentermine; fda; faa; ntsb; fen/phen; fen-phen; drug safety;
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. RACHEL'S ENVIRONMENT & HEALTH WEEKLY #632 .
. ---January 7, 1999--- .
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. ANOTHER KIND OF DRUG PROBLEM .
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