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Dr. Lucian L. Leape opened medicine's
Pandora's box in his 1994 paper, “Error in
Medicine,” which appeared in the
Journal of
the American Medical Association
(JAMA).(16)
He found that Schimmel reported in 1964 that
20% of hospital patients suffered iatrogenic
injury, with a 20% fatality rate. In 1981
Steel reported that 36% of hospitalized
patients experienced iatrogenesis with a 25%
fatality rate, and adverse drug reactions
were involved in 50% of the injuries. In
1991, Bedell reported that 64% of acute
heart attacks in one hospital were
preventable and were mostly due to adverse
drug reactions.
Leape focused on the “Harvard Medical
Practice Study” published in 1991,
(16a)
which found a 4% iatrogenic injury rate for
patients, with a 14% fatality rate, in 1984
in New York State. From the 98,609 patients
injured and the 14% fatality rate, he
estimated that in the entire U.S. 180,000
people die each year partly as a result of
iatrogenic injury.
Why Leape chose to use the much lower
figure of 4% injury for his analysis remains
in question. Using instead the average of
the rates found in the three studies he
cites
(36%, 20%, and 4%) would have
produced a 20% medical error rate. The
number of iatrogenic deaths using an average
rate of injury and his 14% fatality rate
would be 1,189,576.
Leape acknowledged that the literature on
medical errors is sparse and represents only
the tip of the iceberg, noting that when
errors are specifically sought out, reported
rates are “distressingly high.” He cited
several autopsy studies with rates as high
as 35-40% of missed diagnoses causing death.
He also noted that an intensive care unit
reported an average of 1.7 errors per day
per patient, and 29% of those errors were
potentially serious or fatal.
Leape calculated the error rate in the
intensive care unit study. First, he found
that each patient had an average of 178
“activities” (staff/procedure/medical
interactions) a day, of which 1.7 were
errors, which means a 1% failure rate. This
may not seem like much, but Leape cited
industry standards showing that in aviation,
a 0.1% failure rate would mean two unsafe
plane landings per day at Chicago's O'Hare
International Airport; in the US Postal
Service, a 0.1% failure rate would mean
16,000 pieces of lost mail every hour; and
in the banking industry, a 0.1% failure rate
would mean 32,000 bank checks deducted from
the wrong bank account.
In trying to determine why there are so
many medical errors, Leape acknowledged the
lack of reporting of medical errors. Medical
errors occur in thousands of different
locations and are perceived as isolated and
unusual events. But the most important
reason that the problem of medical errors is
unrecognized and growing, according to Leape,
is that doctors and nurses are unequipped to
deal with human error because of the culture
of medical training and practice. Doctors
are taught that mistakes are unacceptable.
Medical mistakes are therefore viewed as a
failure of character and any error equals
negligence. No one is taught what to do when
medical errors do occur. Leape cites
McIntyre and Popper, who said the
“infallibility model” of medicine leads to
intellectual dishonesty with a need to cover
up mistakes rather than admit them. There
are no Grand Rounds on medical errors, no
sharing of failures among doctors, and no
one to support them emotionally when their
error harms a patient.
Leape hoped his paper would encourage
medical practitioners “to fundamentally
change the way they think about errors and
why they occur.” It has been almost a decade
since this groundbreaking work, but the
mistakes continue to soar.
In 1995, a
JAMA
report noted, "Over a million patients
are injured in US hospitals each year, and
approximately 280,000 die annually as a
result of these injuries. Therefore, the
iatrogenic death rate dwarfs the annual
automobile accident mortality rate of 45,000
and accounts for more deaths than all other
accidents combined."(23)
At a 1997 press conference, Leape
released a nationwide poll on patient
iatrogenesis conducted by the National
Patient Safety Foundation (NPSF), which is
sponsored by the American Medical
Association
(AMA).
Leape is a founding member of NPSF. The
survey found that more than 100 million
Americans have been affected directly or
indirectly by a medical mistake. Forty-two
percent were affected directly and 84%
personally knew of someone who had
experienced a medical mistake.(14)
At this press conference, Leape updated
his 1994 statistics, noting that as of 1997,
medical errors in inpatient hospital
settings nationwide could be as high as 3
million and could cost as much as $200
billion . Leape used a 14% fatality rate to
determine a medical error death rate of
180,000 in 1994.(16)
In 1997, using Leape's base number of 3
million errors, the annual death rate could
be as high as 420,000 for hospital
inpatients alone.
ONLY A FRACTION OF
MEDICAL ERRORS ARE REPORTED
In 1994, Leape said he was well aware
that medical errors were not being reported.(16)
A study conducted in two obstetrical units
in the UK found that only about one-quarter
of adverse incidents were ever reported, to
protect staff, preserve reputations, or for
fear of reprisals, including lawsuits.(24).
An analysis by Wald and Shojania found that
only 1.5% of all adverse events result in an
incident report, and only 6% of adverse drug
events are identified properly. The authors
learned that the American College of
Surgeons estimates that surgical incident
reports routinely capture only 5-30% of
adverse events. In one study, only 20% of
surgical complications resulted in
discussion at morbidity and mortality
rounds.(25)
From these studies, it appears that all the
statistics gathered on medical errors may
substantially underestimate the number of
adverse drug and medical therapy incidents.
They also suggest that our statistics
concerning mortality resulting from medical
errors may be in fact be conservative
figures.
An article in
Psychiatric
Times (April 2000) outlines the
stakes involved in reporting medical errors.(26)
The authors found that the public is fearful
of suffering a fatal medical error, and
doctors are afraid they will be sued if they
report an error. This brings up the obvious
question: who is reporting medical errors?
Usually it is the patient or the patient's
surviving family. If no one notices the
error, it is never reported. Janet Heinrich,
an associate director at the U.S. General
Accounting Office responsible for health
financing and public health issues,
testified before a House subcommittee
hearing on medical errors that "the full
magnitude of their threat to the American
public is unknown” and "gathering valid and
useful information about adverse events is
extremely difficult." She acknowledged that
the fear of being blamed, and the potential
for legal liability, played key roles in the
underreporting of errors. The
Psychiatric
Times noted that the AMA
strongly opposes mandatory reporting of
medical errors.(26)
If doctors are not reporting, what about
nurses? A survey of nurses found that they
also fail to report medical mistakes for
fear of retaliation.(27)
Standard medical pharmacology texts admit
that relatively few doctors ever report
adverse drug reactions to the FDA.(28)
The reasons range from not knowing such a
reporting system exists to fear of being
sued.(29)
Yet the public depends on this tremendously
flawed system of voluntary reporting by
doctors to know whether a drug or a medical
intervention is harmful.
Pharmacology texts also will tell doctors
how hard it is to separate drug side effects
from disease symptoms. Treatment failure is
most often attributed to the disease and not
the drug or doctor. Doctors are warned,
“Probably nowhere else in professional life
are mistakes so easily hidden, even from
ourselves.”(30)
It may be hard to accept, but it is not
difficult to understand why only 1 in 20
side effects is reported to either hospital
administrators or the FDA.(31,
31a)
If hospitals admitted to the actual
number of errors for which they are
responsible, which is about 20 times what is
reported, they would come under intense
scrutiny.(32)
Jerry Phillips, associate director of the
FDA's Office of Post Marketing Drug Risk
Assessment, confirms this number. “In the
broader area of adverse drug reaction data,
the 250,000 reports received annually
probably represent only 5% of the actual
reactions that occur.”(33)
Dr. Jay Cohen, who has extensively
researched adverse drug reactions, notes
that because only 5% of adverse drug
reactions are reported, there are in fact 5
million medication reactions each year.(34)
A 2003 survey is all the more distressing
because there seems to be no improvement in
error reporting, even with all the attention
given to this topic. Dr. Dorothea Wild
surveyed medical residents at a community
hospital in Connecticut and found that only
half were aware that the hospital had a
medical error-reporting system, and that the
vast majority did not use it at all. Dr.
Wild says this does not bode well for the
future. If doctors don't learn error
reporting in their training, they will never
use it. Wild adds that error reporting is
the first step in locating the gaps in the
medical system and fixing them. Not even
that first step has been taken to date.(35)
PUBLIC SUGGESTIONS
ON IATROGENESIS
In a telephone survey, 1,207 adults
ranked the effectiveness of the following
measures in reducing preventable medical
errors that result in serious harm.(36)
(Following each measure is the percentage of
respondents who ranked the measure as “very
effective.”)
-
giving doctors more time to spend with
patients (78%)
-
requiring hospitals to develop systems to
avoid medical errors (74%)
-
better training of health professionals
(73%)
-
using only doctors specially trained in
intensive care medicine on intensive care
units (73%)
-
requiring hospitals to report all serious
medical errors to a state agency (71%)
-
increasing the number of hospital nurses
(69%)
-
reducing the work hours of doctors in
training to avoid fatigue (66%)
-
encouraging hospitals to voluntarily
report serious medical errors to a state
agency (62%).
DRUG IATROGENESIS
Prescription drugs constitute the major
treatment modality of scientific medicine.
With the discovery of the “germ theory,”
medical scientists convinced the public that
infectious organisms were the cause of
illness. Finding the “cure” for these
infections proved much harder than anyone
imagined. From the beginning, chemical drugs
promised much more than they delivered. But
far beyond not working, the drugs also
caused incalculable side effects. The drugs
themselves, even when properly prescribed,
have side effects that can be fatal, as
Lazarou's study(1)
showed. But human error can make the
situation even worse.
Medication Errors
A survey of a 1992 national pharmacy
database found a total of 429,827 medication
errors from 1,081 hospitals. Medication
errors occurred in 5.22% of patients
admitted to these hospitals each year. The
authors concluded that at least 90,895
patients annually were harmed by medication
errors in the US as a whole.(37)
A 2002 study shows that 20% of hospital
medications for patients had dosage errors.
Nearly 40% of these errors were considered
potentially harmful to the patient. In a
typical 300-patient hospital, the number of
errors per day was 40.(38)
Problems involving patients' medications
were even higher the following year. The
error rate intercepted by pharmacists in
this study was 24%, making the potential
minimum number of patients harmed by
prescription drugs 417,908.(39)
Recent Adverse Drug Reactions
More-recent studies on adverse drug
reactions show that the figures from 1994
published in Lazarou's 1998
JAMA
article may be increasing. A 2003 study
followed 400 patients after discharge from a
tertiary care hospital setting (requiring
highly specialized skills, technology, or
support services). Seventy-six patients
(19%) had adverse events. Adverse drug
events were the most common, at 66% of all
events. The next most common event was
procedure-related injuries, at 17%.(40)
In a
New England
Journal of Medicine study, an
alarming one in four patients suffered
observable side effects from the more than
3.34 billion prescription drugs filled in
2002.(41)
One of the doctors who produced the study
was interviewed by Reuters and commented,
"With these 10-minute appointments, it's
hard for the doctor to get into whether the
symptoms are bothering the patients."(42)
William Tierney, who editorialized on the
New
England Journal study, said “…
given the increasing number of powerful
drugs available to care for the aging
population, the problem will only get
worse.” The drugs with the worst record of
side effects were selective serotonin
reuptake inhibitors ( SSRIs), nonsteroidal
anti-inflammatory drugs (NSAIDs), and
calcium-channel blockers. Reuters also
reported that prior research has suggested
that nearly 5% of hospital admissions (over
1 million per year) are the result of drug
side effects. But most of the cases are not
documented as such. The study found that one
of the reasons for this failure is that in
nearly two-thirds of the cases, doctors
could not diagnose drug side effects or the
side effects persisted because the doctor
failed to heed the warning signs.
Medicating Our Feelings
Patients seeking a more joyful existence
and relief from worry, stress, and anxiety
often fall victim to the messages endlessly
displayed on TV and billboards. Often,
instead of gaining relief, they fall victim
to the myriad iatrogenic side effects of
antidepressant medication.
Moreover, a whole generation of
antidepressant users has been created from
young people growing up on Ritalin.
Medicating youth and modifying their
emotions must have some impact on how they
learn to deal with their feelings. They
learn to equate coping with drugs rather
than with their inner resources. As adults,
these medicated youth reach for alcohol,
drugs, or even street drugs to cope.
According to
JAMA
, “Ritalin acts much like cocaine.”(43)
Today's marketing of mood-modifying drugs
such as Prozac and Zoloft ® makes them not
only socially acceptable but almost a
necessity in today's stressful world.
Television Diagnosis
To reach the widest audience possible,
drug companies are no longer just targeting
medical doctors with their marketing of
antidepressants. By 1995, drug companies had
tripled the amount of money allotted to
direct advertising of prescription drugs to
consumers. The majority of this money is
spent on seductive television ads. From 1996
to 2000, spending rose from $791 million to
nearly $2.5 billion.(44)
This $2.5 billion represents only 15% of the
total pharmaceutical advertising budget.
While the drug companies maintain that
direct-to-consumer advertising is
educational, Dr. Sidney M. Wolfe of the
Public Citizen Health Research Group in
Washington, DC, argues that the public often
is misinformed about these ads.(45)
People want what they see on television and
are told to go to their doctors for a
prescription. Doctors in private practice
either acquiesce to their patients' demands
for these drugs or spend valuable time
trying to talk patients out of unnecessary
drugs. Dr. Wolfe remarks that one important
study found that people mistakenly believe
that the “FDA reviews all ads before they
are released and allows only the safest and
most effective drugs to be promoted directly
to the public.”(46)
How Do We Know Drugs
Are Safe?
Another aspect of scientific medicine
that the public takes for granted is the
testing of new drugs. Drugs generally are
tested on individuals who are fairly healthy
and not on other medications that could
interfere with findings. But when these new
drugs are declared “safe” and enter the drug
prescription books, they are naturally going
to be used by people who are on a variety of
other medications and have a lot of other
health problems. Then a new phase of drug
testing called “post-approval” comes into
play, which is the documentation of side
effects once drugs hit the market. In one
very telling report, the federal
government's General Accounting Office
"found that of the 198 drugs approved by the
FDA between 1976 and 1985... 102 (or 51.5%)
had serious post-approval risks... the
serious post-approval risks (included) heart
failure, myocardial infarction, anaphylaxis,
respiratory depression and arrest, seizures,
kidney and liver failure, severe blood
disorders, birth defects and fetal toxicity,
and blindness."(47)
NBC Television's investigative show
“Dateline” wondered if your doctor is
moonlighting as a drug company
representative. After a yearlong
investigation, NBC reported that because
doctors can legally prescribe any drug to
any patient for any condition, drug
companies heavily promote "off label" and
frequently inappropriate and untested uses
of these medications, even though these
drugs are approved only for the specific
indications for which they have been tested.(48)
The leading causes of adverse drug
reactions are antibiotics
(17%),
cardiovascular drugs
(17%),
chemotherapy
(15%),
and analgesics and anti-inflammatory agents
(15%).(49)
Specific Drug
Iatrogenesis: Antibiotics
According to William Agger, MD, director
of microbiology and chief of infectious
disease at Gundersen Lutheran Medical Center
in La Crosse, WI, 30 million pounds of
antibiotics are used in America each year.(50)
Of this amount, 25 million pounds are used
in animal husbandry, and 23 million pounds
are used to try to prevent disease and the
stress of shipping, as well as to promote
growth. Only 2 million pounds are given for
specific animal infections. Dr. Agger
reminds us that low concentrations of
antibiotics are measurable in many of our
foods and in various waterways around the
world, much of it seeping in from animal
farms.
Agger contends that overuse of
antibiotics results in food-borne infections
resistant to antibiotics. Salmonella is
found in 20% of ground meat, but the
constant exposure of cattle to antibiotics
has made 84% of salmonella resistant to at
least one anti-salmonella antibiotic.
Diseased animal food accounts for 80% of
salmonellosis in humans, or 1.4 million
cases per year. The conventional approach to
countering this epidemic is to radiate food
to try to kill all organisms while
continuing to use the antibiotics that
created the problem in the first place.
Approximately 20% of chickens are
contaminated with
Campylobacter jejuni, an
organism that causes 2.4 million cases of
illness annually. Fifty-four percent of
these organisms are resistant to at least
one anti-campylobacter antimicrobial agent.
Denmark banned growth-promoting
antibiotics beginning in 1999, which cut
their use by more than half within a year,
from 453,200 to 195,800 pounds. A report
from Scandinavia found that removing
antibiotic growth promoters had no or
minimal effect on food production costs.
Agger warns that the current crowded,
unsanitary methods of animal farming in the
US support constant stress and infection,
and are geared toward high antibiotic use.
In the US, over 3 million pounds of
antibiotics are used every year on humans.
With a population of 284 million Americans,
this amount is enough to give every man,
woman, and child 10 teaspoons of pure
antibiotics per year. Agger says that
exposure to a steady stream of antibiotics
has altered pathogens such as
Streptococcus pneumoniae,
Staplococcus aureus, and
entercocci,
to name a few.
Almost half of patients with upper
respiratory tract infections in the U.S.
still receive antibiotics from their doctor.(51)
According to the CDC, 90% of upper
respiratory infections are viral and should
not be treated with antibiotics. In Germany,
the prevalence of systemic antibiotic use in
children aged 0-6 years was 42.9%.(52)
Data obtained from nine US health
insurers on antibiotic use in 25,000
children from 1996 to 2000 found that rates
of antibiotic use decreased. Antibiotic use
in children aged three months to under 3
years decreased 24%, from 2.46 to 1.89
antibiotic prescriptions per patient per
year. For children aged 3 to under 6 years,
there was a 25% reduction from 1.47 to 1.09
antibiotic prescriptions per patient per
year. And for children aged 6 to under 18
years, there was a 16% reduction from 0.85
to 0.69 antibiotic prescriptions per patient
per year.(53)
Despite these reductions, the data indicate
that on average every child in America
receives 1.22 antibiotic prescriptions
annually.
Group A beta-hemolytic streptococci is
the only common cause of sore throat that
requires antibiotics, with penicillin and
erythromycin the only recommended treatment.
Ninety percent of sore-throat cases,
however, are viral. Antibiotics were used in
73% of the estimated 6.7 million adult
annual visits for sore throat in the US
between 1989 and 1999. Furthermore, patients
treated with antibiotics were prescribed
non-recommended broad-spectrum antibiotics
in 68% of visits. This period saw a
significant increase in the use of newer,
more expensive broad-spectrum antibiotics
and a decrease in use of the recommended
antibiotics penicillin and erythromycin.(54)
A ntibiotics being prescribed in 73% of
sore-throat cases instead of the recommended
10% resulted in a total of 4.2 million
unnecessary antibiotic prescriptions from
1989 to 1999.
The Problem with
Antibiotics
In September 2003, the CDC re-launched a
program started in 1995 called “Get Smart:
Know When Antibiotics Work.”(55)
This $1.6 million campaign is designed to
educate patients about the overuse and
inappropriate use of antibiotics. Most
people involved with alternative medicine
have known about the dangers of antibiotic
overuse for decades. Finally the government
is focusing on the problem, yet it is
spending only a miniscule amount of money on
an iatrogenic epidemic that is costing
billions of dollars and thousands of lives.
The CDC warns that 90% of upper respiratory
infections, including children's ear
infections, are viral and that antibiotics
do not treat viral infection. More than 40%
of about 50 million prescriptions for
antibiotics written each year in physicians'
offices are inappropriate.(2)
U sing antibiotics when not needed can lead
to the development of deadly strains of
bacteria that are resistant to drugs and
cause more than 88,000 deaths due to
hospital-acquired infections.(9)
The CDC, however, seems to be blaming
patients for misusing antibiotics even
though they are available only by
prescription from physicians. According to
Dr. Richard Besser, head of “Get Smart”:
"Programs that have just targeted physicians
have not worked. Direct-to-consumer
advertising of drugs is to blame in some
cases.” Besser says the program “teaches
patients and the general public that
antibiotics are precious resources that must
be used correctly if we want to have them
around when we need them. Hopefully, as a
result of this campaign, patients will feel
more comfortable asking their doctors for
the best care for their illnesses, rather
than asking for antibiotics."(56) |
