By
Gary Null PhD, Carolyn Dean MD ND, Martin Feldman MD,
Debora Rasio MD, Dorothy Smith PhD
ABSTRACT Iatrogenesis
means an illness caused by doctors or medical
intervention
A definitive review
and close reading of medical peer-review journals, and
government health statistics shows that American
medicine frequently causes more harm than good. The
number of people having in-hospital, adverse drug
reactions (ADR) to prescribed medicine is 2.2 million.1
Dr. Richard Besser, of the CDC, in 1995, said the number
of unnecessary antibiotics prescribed annually for viral
infections was 20 million. Dr. Besser, in 2003, now
refers to tens of millions of unnecessary antibiotics.2,
2a
The number of
unnecessary medical and surgical procedures performed
annually is 7.5 million.3 The number of
people exposed to unnecessary hospitalization annually
is 8.9 million.4 The total number of
iatrogenic deaths shown in the following table is
783,936. It is evident that the American medical system
is the leading cause of death and injury in the United
States. The 2001 heart disease annual death rate is
699,697; the annual cancer death rate, 553,251.5
TABLES AND
FIGURES (see Section on Statistical Tables and Figures,
below, for exposition)
ANNUAL PHYSICAL
AND ECONOMIC COST OF MEDICAL INTERVENTION
Condition |
Deaths |
Cost |
Author |
Adverse Drug Reactions
|
106,000 |
$12 billion |
Lazarou1 Suh49
|
Medical error |
98,000 |
$2 billion |
IOM6 |
Bedsores |
115,000 |
$55 billion |
Xakellis7
Barczak8 |
Infection |
88,000 |
$5 billion |
Weinstein9
MMWR10 |
Malnutrition |
108,800 |
-------- |
Nurses Coalition11
|
Outpatients |
199,000 |
$77 billion |
Starfield12
Weingart112 |
Unnecessary Procedures |
37,136 |
$122 billion |
HCUP3,13
|
Surgery-Related |
32,000 |
$9 billion |
AHRQ85 |
TOTAL |
783,936 |
$282 billion |
|
We could have an
even higher death rate by using Dr. Lucien Leape’s 1997
medical and drug error rate of 3 million. 14
Multiplied by the fatality rate of 14% (that Leape used
in 199416 we arrive at an annual death rate
of 420,000 for drug errors and medical errors combined.
If we put this number in place of Lazorou’s 106,000 drug
errors and the Institute of Medicine’s (IOM) 98,000
medical errors, we could add another 216,000 deaths
making a total of 999,936 deaths annually.
Condition |
Deaths |
Cost |
Author |
ADR/med error |
420,000 |
$200 billion |
Leape 199714 |
TOTAL |
999,936 |
|
|
ANNUAL
UNNECESSARY MEDICAL EVENTS STATISTICS
Unnecessary Events |
People Affected |
Iatrogenic Events |
Hospitalization |
8.9 million4 |
1.78 million16 |
Procedures |
7.5 million3 |
1.3 million40 |
TOTAL |
16.4 million |
3.08 million |
The enumerating of
unnecessary medical events is very important in our
analysis. Any medical procedure that is invasive and not
necessary must be considered as part of the larger
iatrogenic picture. Unfortunately, cause and effect go
unmonitored. The figures on unnecessary events represent
people (“patients”) who are thrust into a dangerous
healthcare system. They are helpless victims. Each one
of these 16.4 million lives is being affected in a way
that could have a fatal consequence. Simply entering a
hospital could result in the following:
1.
In 16.4
million people, 2.1% chance of a serious adverse drug
reaction,1 (186,000)
2.
In 16.4
million people, 5-6% chance of acquiring a nosocomial
infection,9 (489,500)
3.
In16.4
million people, 4-36% chance of having an iatrogenic
injury in hospital (medical error and adverse drug
reactions),16 (1.78 million)
4.
In 16.4
million people, 17% chance of a procedure error,40 (1.3
million)
All the statistics
above represent a one-year time span. Imagine the
numbers over a ten-year period. Working with the most
conservative figures from our statistics we project the
following 10-year death rates.
TEN-YEAR DEATH
RATES FOR MEDICAL INTERVENTION
Condition |
10-Year Deaths |
Author |
Adverse Drug Reaction |
1.06 million |
(1) |
Medical error |
0.98 million |
(6) |
Bedsores |
1.15 million |
(7,8) |
Nosocomial Infection |
0.88 million |
(9,10) |
Malnutrition |
1.09 million |
(11) |
Outpatients |
1.99 million |
(12, 112) |
Unnecessary Procedures |
371,360 |
(3,13) |
Surgery-related |
320,000 |
(85) |
TOTAL 7,841,360 (7.8 million) |
|
|
Our projected
statistic of 7.8 million iatrogenic deaths is more than
all the casualties from wars that America has fought in
its entire history.
Our projected
figures for unnecessary medical events occurring over a
10-year period are also dramatic.
TEN-YEAR
STATISTICS FOR UNNECESSARY INTERVENTION
Unnecessary Events
|
10-year Number |
Iatrogenic Events |
Hospitalization |
89 million4 |
17 million |
Procedures |
75 million3 |
15 million |
TOTAL 164 million |
|
|
These projected
figures show that a total of 164 million people,
approximately 56% of the population of the United
States, have been treated unnecessarily by the medical
industry – in other words, nearly 50,000 people per day.
INTRODUCTION
Never before have
the complete statistics on the multiple causes of
iatrogenesis been combined in one paper. Medical science
amasses tens of thousands of papers annually--each one a
tiny fragment of the whole picture. To look at only one
piece and try to understand the benefits and risks is to
stand one inch away from an elephant and describe
everything about it. You have to pull back to reveal the
complete picture, such as we have done here. Each
specialty, each division of medicine, keeps their own
records and data on morbidity and mortality like pieces
of a puzzle. But the numbers and statistics were always
hiding in plain sight. We have now completed the
painstaking work of reviewing thousands and thousands of
studies. Finally putting the puzzle together we came up
with some disturbing answers.
Is American
Medicine Working?
At 14 percent of the
Gross National Product, health care spending reached
$1.6 trillion in 2003.15 Considering this enormous
expenditure, we should have the best medicine in the
world. We should be reversing disease, preventing
disease, and doing minimal harm. However, careful and
objective review shows the opposite. Because of the
extraordinary narrow context of medical technology
through which contemporary medicine examines the human
condition, we are completely missing the full picture.
Medicine is not
taking into consideration the following monumentally
important aspects of a healthy human organism: (a)
stress and how it adversely affects the immune system
and life processes; (b) insufficient exercise; (c)
excessive caloric intake; (d) highly-processed and
denatured foods grown in denatured and
chemically-damaged soil; and (e) exposure to tens of
thousands of environmental toxins. Instead of minimizing
these disease-causing factors, we actually cause more
illness through medical technology, diagnostic testing,
overuse of medical and surgical procedures, and overuse
of pharmaceutical drugs. The huge disservice of this
therapeutic strategy is the result of little effort or
money being appropriated for preventing disease.
Under-reporting
of Iatrogenic Events
As few as 5 percent
and only up to 20 percent of iatrogenic acts are ever
reported.16,24,25,33,34 This implies that if medical
errors were completely and accurately reported, we would
have a much higher annual iatrogenic death rate than
783,936. Dr. Leape, in 1994, said his figure of 180,000
medical mistakes annually was equivalent to three
jumbo-jet crashes every two days.16 Our report shows
that six jumbo jets are falling out of the sky each and
every day.
Correcting a
Compromised System
What we must deduce
from this report is that medicine is in need of complete
and total reform: from the curriculum in medical schools
to protecting patients from excessive medical
intervention. It is quite obvious that we can’t change
anything if we are not honest about what needs to be
changed. This report simply shows the degree to which
change is required.
We are fully aware
that what stands in the way of change are powerful
pharmaceutical companies, medical technology companies,
and special interest groups with enormous vested
interests in the business of medicine. They fund medical
research, support medical schools and hospitals, and
advertise in medical journals. With deep pockets they
entice scientists and academics to support their
efforts. Such funding can sway the balance of opinion
from professional caution to uncritical acceptance of a
new therapy or drug.
You only have to
look at the number of invested people on hospital,
medical, and government health advisory boards to see
conflict of interest. The public is mostly unaware of
these interlocking interests. For example, a 2003 study
found that nearly half of medical school faculty, who
serve on Institutional Review Boards (IRB) to advise on
clinical trial research, also serve as consultants to
the pharmaceutical industry.17 The authors were
concerned that such representation could cause potential
conflicts of interest.
A news release by
Dr. Erik Campbell, the lead author, said, "Our previous
research with faculty has shown us that ties to industry
can affect scientific behavior, leading to such things
as trade secrecy and delays in publishing research. It's
possible that similar relationships with companies could
affect IRB members' activities and attitudes."18
Medical Ethics
and Conflict of Interest in Scientific Medicine
Jonathan Quick,
director of Essential Drugs and Medicines Policy for the
World Health Organization (WHO) wrote in a recent WHO
Bulletin: "If clinical trials become a commercial
venture in which self-interest overrules public interest
and desire overrules science, then the social contract
which allows research on human subjects in return for
medical advances is broken."19
Former editor of the
New England Journal of Medicine (NEJM), Dr. Marcia
Angell, struggled to bring the attention of the world to
the problem of commercializing scientific research in
her outgoing editorial titled "Is Academic Medicine for
Sale?"20 Angell called for stronger restrictions on
pharmaceutical stock ownership and other financial
incentives for researchers. She said that growing
conflicts of interest are tainting science.
She warned that,
"When the boundaries between industry and academic
medicine become as blurred as they are now, the business
goals of industry influence the mission of medical
schools in multiple ways." She did not discount the
benefits of research but said a Faustian bargain now
existed between medical schools and the pharmaceutical
industry.
Angell left the NEMJ
in June 2000. Two years later, in June 2002, the NEJM
announced that it would now accept biased journalists
(those who accept money from drug companies) because it
is too difficult to find ones who have no ties. Another
former editor of the journal, Dr. Jerome Kassirer, said
that was just not the case, that there are plenty of
researchers who don’t work for drug companies.21 The ABC
report said that one measurable tie between
pharmaceutical companies and doctors amounts to over $2
billion a year spent for over 314,000 events that
doctors attend.
The ABC report also
noted that a survey of clinical trials revealed that
when a drug company funds a study, there is a 90 percent
chance that the drug will be perceived as effective
whereas a non-drug company-funded study will show
favorable results 50 percent of the time. It appears
that money can’t buy you love but it can buy you any
"scientific" result you want. The only safeguard to
reporting these studies was if the journal writers
remained unbiased. That is no longer the case.
Cynthia Crossen,
writer for the Wall Street Journal in 1996, published
Tainted Truth: The Manipulation of Fact in America, a
book about the widespread practice of lying with
statistics.22 Commenting on the state of scientific
research she said that, "The road to hell was paved with
the flood of corporate research dollars that eagerly
filled gaps left by slashed government research
funding." Her data on financial involvement showed that
in l981 the drug industry "gave" $292 million to
colleges and universities for research. In l991 it
"gave" $2.1 billion.
THE FIRST
IATROGENIC STUDY
Dr. Lucian L. Leape
opened medicine’s Pandora’s box in his 1994 JAMA paper,
"Error in Medicine".16 He began the paper by reminiscing
about Florence Nightingale’s maxim--"first do no harm."
But he found evidence of the opposite happening in
medicine. He found that Schimmel reported in 1964 that
20 percent of hospital patients suffered iatrogenic
injury, with a 20 percent fatality rate. Steel in 1981
reported that 36 percent of hospitalized patients
experienced iatrogenesis with a 25 percent fatality rate
and adverse drug reactions were involved in 50 percent
of the injuries. Bedell in 1991 reported that 64 percent
of acute heart attacks in one hospital were preventable
and were mostly due to adverse drug reactions.
However, Leape
focused on his and Brennan’s "Harvard Medical Practice
Study" published in 1991.16a They found that in 1984, in
New York State, there was a 4 percent iatrogenic injury
rate for patients with a 14 percent fatality rate. From
the 98,609 patients injured and the 14 percent fatality
rate, he estimated that in the whole of the U.S. 180,000
people die each year, partly as a result of iatrogenic
injury. Leape compared these deaths to the equivalent of
three jumbo-jet crashes every two days.
Why Leape chose to
use the much lower figure of four percent injury for his
analysis remains in question. Perhaps he wanted to tread
lightly. If Leape had, instead, calculated the average
rate among the three studies he cites (36 percent, 20
percent, and 4 percent), he would have come up with a 20
percent medical error rate. The number of fatalities
that he could have presented, using an average rate of
injury and his 14 percent fatality, is an annual
1,189,576 iatrogenic deaths, or over ten jumbo jets
crashing every day.
Leape acknowledged
that the literature on medical error is sparse and we
are only seeing the tip of the iceberg. He said that
when errors are specifically sought out, reported rates
are "distressingly high". He cited several autopsy
studies with rates as high as 35 percent to 40 percent
of missed diagnoses causing death. He also commented
that an intensive care unit reported an average of 1.7
errors per day per patient, and 29 percent of those
errors were potentially serious or fatal. We wonder:
what is the effect on someone who daily gets the wrong
medication, the wrong dose, the wrong procedure; how do
we measure the accumulated burden of injury; and when
the patient finally succumbs after the tenth error that
week, what is entered on the death certificate?
Leape calculated the
rate of error in the intensive care unit. 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 percent
failure rate. To some this may not seem like much, but
putting this into perspective, Leape cited industry
standards where in aviation a 0.1 percent failure rate
would mean 2 unsafe plane landings per day at O’Hare
airport; in the U.S. Mail, 16,000 pieces of lost mail
every hour; or in banking, 32,000 bank checks deducted
from the wrong bank account every hour.
Analyzing why there
is so much medical error Leape acknowledged the lack of
reporting. Unlike a jumbo-jet crash, which gets instant
media coverage, hospital errors are spread out over the
country in thousands of different locations. They are
also perceived as isolated and unusual events. However,
the most important reason that medical error is
unrecognized and growing, according to Leape, was, and
still is, that doctors and nurses are unequipped to deal
with human error, due to 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. We can see how a great deal of
sweeping under the rug takes place since nobody is
taught what to do when medical error does occur. Leape
cited 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 medicine "to fundamentally change
the way they think about errors and why they occur".
It’s been almost a decade since this groundbreaking
work, but the mistakes continue to soar.
One year later, in
1995, a report in JAMA said that, "Over a million
patients are injured in U.S. 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 press
conference in 1997 Dr. Leape released a nationwide poll
on patient iatrogenesis conducted by the National
Patient Safety Foundation (NPSF), which is sponsored by
the American Medical Association. The survey found that
more than 100 million Americans have been impacted
directly and indirectly by a medical mistake. Forty-two
percent were directly affected and a total of 84 percent
personally knew of someone who had experienced a medical
mistake.14 Dr. Leape is a founding member of the NPSF.
Dr. Leape at this
press conference also updated his 1994 statistics saying
that medical errors in inpatient hospital settings
nationwide, as of 1997, could be as high as three
million and could cost as much as $200 billion. Leape
used a 14 percent fatality rate to determine a medical
error death rate of 180,000 in 1994.16 In 1997, using
Leape’s base number of three million errors, the annual
deaths could be as much as 420,000 for inpatients alone.
This does not include nursing home deaths, or people in
the outpatient community dying of drug side effects or
as the result of medical procedures.
ONLY A FRACTION
OF MEDICAL ERRORS ARE REPORTED
Leape, in 1994, said
that he was well aware that medical errors were not
being reported.16 According to a study in two
obstetrical units in the U.K., only about one quarter of
the adverse incidents on the units are ever reported for
reasons of protecting staff or preserving reputations,
or fear of reprisals, including law suits.24 An analysis
by Wald and Shojania found that only 1.5 percent of all
adverse events result in an incident report, and only 6
percent of adverse drug events are identified properly.
The authors learned
that the American College of Surgeons gives a very broad
guess that surgical incident reports routinely capture
only 5-30 percent of adverse events. In one surgical
study only 20 percent of surgical complications resulted
in discussion at Morbidity and Mortality Rounds.25 From
these studies it appears that all the statistics that
are gathered may be substantially underestimating the
number of adverse drug and medical therapy incidents. It
also underscores the fact that our mortality statistics
are actually conservative figures.
An article in
Psychiatric Times outlines the stakes involved with
reporting medical errors.26 They 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, testifying before a House subcommittee
about medical errors, said that, "The full magnitude of
their threat to the American public is unknown." She
added, "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 under-reporting
of errors. The Psychiatric Times noted that the American
Medical Association is strongly opposed to mandatory
reporting of medical errors.26 If doctors aren’t
reporting, what about nurses? In a survey of nurses,
they also did not 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 because they prescribed a
drug that caused harm. 29 However, it is this
tremendously flawed system of voluntary reporting from
doctors that we depend on to know whether a drug or a
medical intervention is harmful.
Pharmacology texts
will also 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
the 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 not
difficult to understand, why only one in twenty side
effects is reported to either hospital administrators or
the FDA.31,31a
If hospitals
admitted to the actual number of errors and mistakes,
which is about 20 times what is reported, they would
come under intense scrutiny.32 Jerry Phillips, associate
director of the Office of Post Marketing Drug Risk
Assessment at the FDA, confirms this number. "In the
broader area of adverse drug reaction data, the 250,000
reports received annually probably represent only five
percent of the actual reactions that occur."33 Dr. Jay
Cohen, who has extensively researched adverse drug
reactions, comments that because only five percent of
adverse drug reactions are being reported, there are, in
reality, five million medication reactions each year.34
It remains that
whatever figure you choose to believe about the side
effects from drugs, all the experts agree that you have
to multiply that by 20 to get a more accurate estimate
of what is really occurring in the burgeoning "field" of
iatrogenic medicine.
A 2003 survey is all
the more distressing because there seems to be no
improvement in error-reporting even with all the
attention on this topic. Dr. Dorothea Wild surveyed
medical residents at a community hospital in
Connecticut. She found that only half of the residents
were aware that the hospital had a medical
error-reporting system, and the vast majority didn’t 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. And she adds that
error reporting is the first step in finding out where
the gaps in the medical system are and fixing them. That
first baby step has not even begun.35
PUBLIC
SUGGESTIONS ON IATROGENESIS
In a telephone
survey, 1,207 adults were asked to indicate how
effective they thought the following would be in
reducing preventable medical errors that resulted in
serious harm:36
-
giving doctors more time to spend with patients:
very effective 78 percent
-
requiring hospitals to develop systems to avoid
medical errors: very effective 74 percent
-
better training of health professionals: very
effective 73 percent
-
using only doctors specially trained in intensive
care medicine on intensive care units: very
effective 73 percent
-
requiring hospitals to report all serious medical
errors to a state agency: very effective 71 percent
-
increasing the number of hospital nurses: very
effective 69 percent
-
reducing the work hours of doctors-in-training to
avoid fatigue: very effective 66 percent
-
encouraging hospitals to voluntarily report serious
medical errors to a state agency: very effective 62
percent
DRUG IATROGENESIS
Drugs comprise 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 study1 shows.
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 percent of patients admitted to
these hospitals each year. The authors concluded that a
minimum of 90,895 patients annually were harmed by
medication errors in the country as a whole.37
A 2002 study shows
that 20 percent of hospital medications for patients had
dosage mistakes. Nearly 40 percent of these errors were
considered potentially harmful to the patient. In a
typical 300-patient hospital the number of errors per
day were 40.38
Problems involving
patients’ medications were even higher the following
year. The error rate intercepted by pharmacists in this
study was 24 percent, 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 (hospital care
that requires highly specialized skills, technology or
support services). Seventy-six patients (19 percent) had
adverse events. Adverse drug events were the most common
at 66 percent. The next most common events were
procedure-related injuries at 17 percent.40
In a NEJM 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 that,
"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 NEJM 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 the SSRIs, the NSAIDs,
and calcium-channel blockers. Reuters also reported that
prior research has suggested that nearly five percent 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 one of the
reasons for this failure: in nearly two-thirds of the
cases, doctors couldn’t diagnose drug side effects or
the side effects persisted because the doctor failed to
heed the warning signs.
Medicating Our
Feelings
We only need to look
at the side effects of antidepressant drugs, which give
hope to a depressed population. Patients seeking a more
joyful existence and relief from worry, stress and
anxiety, fall victim to the messages blatantly displayed
on TV and billboards. Often, instead of relief, they
also fall victim to a myriad of iatrogenic side effects
of antidepressant medication.
Also, a whole
generation of antidepressant users has resulted 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 and not their inner resources.
As adults, these medicated youth reach for alcohol,
drugs, or even street drugs, to cope. According to the
Journal of the American Medical Association, "Ritalin
acts much like cocaine."43 Today’s marketing of
mood-modifying drugs, such as Prozac or Zoloft, makes
them not only socially acceptable but almost a necessity
in today’s stressful world.
Television
Diagnosis
In order to reach
the widest audience possible, drug companies are no
longer just targeting medical doctors with their message
about antidepressants. By 1995 drug companies had
tripled the amount of money allotted to direct
advertising of prescription drugs to consumers. The
majority of the money is spent on seductive television
ads. From 1996 to 2000, spending rose from $791 million
to nearly $2.5 billion.44 Even though $2.5 billion may
seem like a lot of money, the authors comment that it
only represents 15 percent of the total pharmaceutical
advertising budget.
According to medical
experts "there is no solid evidence on the
appropriateness of prescribing that results from
consumers requesting an advertised drug." However, the
drug companies maintain that direct-to-consumer
advertising is educational. Dr. Sidney M. Wolfe, of the
Public Citizen Health Research Group in Washington,
D.C., argues that the public is often misinformed about
these ads.45 People want what they see on television and
are told to go to their doctor for a prescription.
Doctors in private
practice either acquiesce to their patients’ demands for
these drugs or spend valuable clinic 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. Unlike the class of people
that take drugs who are ill and need medication, in
general, drugs are tested on individuals who are fairly
healthy and not on other medications that can interfere
with findings. But when they are declared "safe" and
enter the drug prescription books, they are naturally
going to be used by people on a variety of other
medications and who also 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 General
Accounting Office (an agency of the U.S. Government)
"found that of the 198 drugs approved by the FDA between
1976 and 1985 ... 102 (or 51.5 percent) 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
The investigative
show NBC’s "Dateline" wondered if your doctor is
moonlighting as a drug rep. After a year-long
investigation they 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 non-tested uses of
these medications in spite of the fact that these drugs
are only approved for specific indications they have
been tested for.48
The leading causes
of adverse drug reactions are antibiotics (17 percent),
cardiovascular drugs (17 percent), chemotherapy (15
percent), and analgesics and anti-inflammatory agents
(15 percent).49
Specific Drug
Iatrogenesis: Antibiotics
Dr. Egger, in a
recent editorial, wrote that after 50 years of
increasing use of antibiotics, 30 million pounds of
antibiotics are used in America per year.50 Twenty-five
million pounds of this total are used in animal
husbandry. The vast majority of this amount, 23 million
pounds, is used to try to prevent disease, the stress of
shipping, and to promote growth. Only 2 million pounds
are given for specific animal infections. Dr. Egger
reminds us that low concentrations of antibiotics are
measurable in many of our foods, rivers, and streams
around the world. Much of this is seeping into bodies of
water from animal farms.
Egger says overuse
of antibiotics results in food-borne infections
resistant to antibiotics. Salmonella is found in 20
percent of ground meat but constant exposure of cattle
to antibiotics has made 84 percent of salmonella
resistant to at least one anti-salmonella antibiotic.
Diseased animal food accounts for 80 percent of
salmonellosis in humans, or 1.4 million cases per year.
The conventional
approach to dealing with this epidemic is to radiate
food to try to kill all organisms but keep using the
antibiotics that cause the original problem.
Approximately 20 percent of chickens are contaminated
with Campylobacter jejuni causing 2.4 million human
cases of illness annually. Fifty-four percent of these
organisms are resistant to at least one
anti-campylobacter antimicrobial.
A ban on
growth-promoting antibiotics in Denmark began in 1999,
which led to a decrease from 453,200 pounds to 195,800
pounds within a year. Another report from Scandinavia
found that taking away antibiotic growth promoters had
no or minimal effect on food production costs. Egger
further warns that in America the current crowded,
unsanitary methods of animal farming support constant
stress and infection, and are geared toward high
antibiotic use. He says these conditions would have to
be changed along with cutting back on antibiotic use.
In America, 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. Egger 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
United States still receive antibiotics from their
doctor.51 According to the CDC, 90 percent of upper
respiratory infections are viral and should not be
treated with antibiotics. In Germany the prevalence for
systemic antibiotic use in children aged 0 to 6 years
was 42.9 percent.52
Data taken from nine
U.S. health plans between 1996 and 2000 on antibiotic
use in 25,000 children found that rates of antibiotic
use decreased. Antibiotic use in children, aged 3 months
to under 3 years, decreased 24 percent, from 2.46 to
1.89 antibiotic prescriptions per/patient per/year. For
children, 3 years to under 6 years, there was a 25
percent 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 percent
reduction from 0.85 to 0.69 antibiotic prescriptions
per/ patient /per year.53 Although there was a reduction
in antibiotic use, 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, penicillin and
erythromycin being the only recommended treatment.
However, 90 percent of sore throats are viral. The
authors of this study estimated there were 6.7 million
adult annual visits for sore throat between 1989 and
1999 in the United States. Antibiotics were used in 73
percent of visits. Furthermore, patients treated with
antibiotics were given non-recommended broad-spectrum
antibiotics in 68 percent of visits.
The authors noted,
that from 1989 to 1999, there was a significant increase
in the newer and more expensive broad-spectrum
antibiotics and a decrease in use of penicillin and
erythromycin, which are the recommended antibiotics.54
If antibiotics were given in 73 percent of visits and
should have only been given in 10 percent, this
represents 63 percent, or a total of 4.2 million visits
for sore throat that ended in unnecessary antibiotic
prescriptions between1989 and 1999. In 1995, Dr. Besser
and the CDC cited 2003 cited much higher figures of 20
million unnecessary antibiotic prescriptions per year
for viral infections.2 Neither of these figures takes
into account the number of unnecessary antibiotics used
for non-fatal conditions such as acne, intestinal
infection, skin infections, ear infections, etc.
The Problem with
Antibiotics: They are Anti-Life
On September 17,
2003 the CDC relaunched a program, started in 1995,
called "Get Smart: Know When Antibiotics Work."55 This
is a $1.6 million campaign to educate patients about the
overuse and inappropriate use of antibiotics. Most
people involved with alternative medicine have known
about the dangers of overuse of antibiotics for decades.
Finally the government is focusing on the problem, yet
they are only putting a miniscule amount of money into
an iatrogenic epidemic that is costing billions of
dollars and thousands of lives.
The CDC warns that
90 percent of upper respiratory infections, including
children’s ear infections, are viral, and antibiotics
don’t treat viral infection. More than 40 percent of
about 50 million prescriptions for antibiotics each year
in physicians' offices were inappropriate.2 And using
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
However, the CDC
seems to be blaming patients for misusing antibiotics
even though they are only available on prescription from
a doctor who should know how to prescribe properly. Dr.
Richard Besser, head of "Get Smart," says "Programs that
have just targeted physicians have not worked.
Direct-to-consumer advertising of drugs is to blame in
some cases." Dr. 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
And what does the
"best care" constitute? The CDC does not elaborate and
patently avoids the latest research on the dozens of
nutraceuticals scientifically proven to treat viral
infections and boost the immune system. Will their
doctors recommend vitamin C, echinacea, elderberry,
vitamin A, zinc, or homeopathic oscillococcinum? No,
they won’t. The archaic solutions offered by the CDC
include a radio ad, "Just Say No--Snort, sniffle,
sneeze--No antibiotics please." Their commonsense
recommendations, that most people do anyway, include
resting, drinking plenty of fluids, and using a
humidifier.
The pharmaceutical
industry claims they are all for limiting the use of
antibiotics. In order to make sure that happens, the
drug company Bayer is sponsoring a program called,
"Operation Clean Hands," through an organization called
LIBRA.57 The CDC is also involved with trying to
minimize antibiotic resistance, but nowhere in their
publications is there any reference to the role of
nutraceuticals in boosting the immune system nor to the
thousands of journal articles that support this
approach.
This recalcitrant
tunnel vision and refusal to use available non-drug
alternatives is absolutely inappropriate when the CDC is
desperately trying to curb the nightmare of overuse of
antibiotics. The CDC should also be called to task
because it is only focusing on the overuse of
antibiotics. There are similar nightmares for every
class of drug being prescribed today.
Drugs Pollute Our
Water Supply
We have reached the
point of saturation with prescription drugs. We have
arrived at the point where every body of water tested
contains measurable drug residues. We are inundated with
drugs. The tons of antibiotics used in animal farming,
which run off into the water table and surrounding
bodies of water, are conferring antibiotic resistance to
germs in sewage, and these germs are also found in our
water supply.
Flushed down our
toilets are tons of drugs and drug metabolites that also
find their way into our water supply. We have no idea
what the long-term consequences of ingesting a mixture
of drugs and drug-breakdown products will do to our
health. It’s another level of iatrogenic disease that we
are unable to completely measure.58-67
Specific Drug
Iatrogenesis: NSAIDs
It’s not just
America that is plagued with iatrogenesis. A survey of
1,072 French general practitioners (GPs) tested their
basic pharmacological knowledge and practice in
prescribing NSAIDs. Non-steroidal anti-inflammatory
drugs (NSAIDs) rank first among commonly prescribed
drugs for serious adverse reactions. The results of the
study suggested that GPs don’t have adequate knowledge
of these drugs and are unable to effectively manage
adverse reactions.68
A cross-sectional
survey of 125 patients attending specialty pain clinics
in South London found that possible iatrogenic factors
such as "over-investigation, inappropriate information,
and advice given to patients as well as misdiagnosis,
over-treatment, and inappropriate prescription of
medication were common."69
Specific Drug
Iatrogenesis: Cancer Chemotherapy
In 1989, a German
biostatistician, Ulrich Abel PhD, after publishing
dozens of papers on cancer chemotherapy, wrote a
monograph "Chemotherapy of Advanced Epithelial Cancer."
It was later published in a shorter form in a
peer-reviewed medical journal.70 Dr. Abel presented a
comprehensive analysis of clinical trials and
publications representing over 3,000 articles examining
the value of cytotoxic chemotherapy on advanced
epithelial cancer. Epithelial cancer is the type of
cancer we are most familiar with. It arises from
epithelium found in the lining of body organs such as
breast, prostate, lung, stomach, or bowel.
From these sites
cancer usually infiltrates into adjacent tissue and
spreads to bone, liver, lung, or the brain. With his
exhaustive review Dr. Abel concludes that there is no
direct evidence that chemotherapy prolongs survival in
patients with advanced carcinoma. He said that in
small-cell lung cancer and perhaps ovarian cancer the
therapeutic benefit is only slight. Dr. Abel goes on to
say, "Many oncologists take it for granted that response
to therapy prolongs survival, an opinion which is based
on a fallacy and which is not supported by clinical
studies."
Over a decade after
Dr. Abel’s exhaustive review of chemotherapy, there
seems no decrease in its use for advanced carcinoma. For
example, when conventional chemotherapy and radiation
has not worked to prevent metastases in breast cancer,
high-dose chemotherapy (HDC) along with stem-cell
transplant (SCT) is the treatment of choice. However, in
March 2000, results from the largest multi-center
randomized controlled trial conducted thus far showed
that, compared to a prolonged course of monthly
conventional-dose chemotherapy, HDC and SCT were of no
benefit.71 There was even a slightly lower survival rate
for the HDC/SCT group. And the authors noted that
serious adverse effects occurred more often in the HDC
group than the standard-dose group. There was one
treatment-related death (within 100 days of therapy) in
the HDC group, but none in the conventional chemotherapy
group. The women in this trial were highly selected as
having the best chance to respond.
There is also no
all-encompassing follow-up study like Dr. Abel’s that
tells us if there is any improvement in cancer-survival
statistics since 1989. In fact, we need to research
whether chemotherapy itself is responsible for secondary
cancers instead of progression of the original disease.
We continue to question why well-researched alternative
cancer treatments aren’t used.
Drug Companies
Fined
Periodically, a drug
manufacturer is fined by the FDA when the abuses are too
glaring and impossible to cover up. The May 2002
Washington Post reported that the maker of Claritin,
Schering-Plough Corp., was to pay a $500 million fine to
the FDA for quality-control problems at four of its
factories.72 The FDA tabulated infractions that included
90 percent, or 125 of the drugs they made since 1998.
Besides the fine, the company had to stop manufacturing
73 drugs or suffer another $175 million fine. PR
statements by the company told another story. The
company assured consumers that they should still feel
confident in its products.
Such a large
settlement serves as a warning to the drug industry
about maintaining strict manufacturing practices and has
given the FDA more clout in dealing with drug company
compliance. According to the Washington Post article, a
federal appeals court ruled in 1999 that the FDA could
seize the profits of companies that violate "good
manufacturing practices." Since that time Abbott
Laboratories Inc. paid $100 million for failing to meet
quality standards in the production of medical test
kits, and Wyeth Laboratories Inc. paid $30 million in
2000 to settle accusations of poor manufacturing
practices.
The indictment
against Schering-Plough came after the Public Citizen
Health Research Group, lead by Dr. Sidney Wolfe, called
for a criminal investigation of Schering-Plough,
charging that the company distributed albuterol asthma
inhalers even though it knew the units were missing the
active ingredient.
UNNECESSARY
SURGICAL PROCEDURES
Summary:
1974: 2.4 million
unnecessary surgeries performed annually resulting in
11,900 deaths at an annual cost of $3.9 billion.73,74
2001: 7.5 million
unnecessary surgical procedures resulting in 37,136
deaths at a cost of $122 billion (using 1974 dollars).3
It’s very difficult
to obtain accurate statistics when studying unnecessary
surgery. Dr. Leape in 1989 wrote that perhaps 30 percent
of controversial surgeries are unnecessary.
Controversial surgeries include Cesarean section,
tonsillectomy, appendectomy, hysterectomy, gastrectomy
for obesity, breast implants, and elective breast
implants.74
Almost 30 years ago,
in 1974, the Congressional Committee on Interstate and
Foreign Commerce held hearings on unnecessary surgery.
They found that 17.6 percent of recommendations for
surgery were not confirmed by a second opinion. The
House Subcommittee on Oversight and Investigations
extrapolated these figures and estimated that, on a
nationwide basis, there were 2.4 million unnecessary
surgeries performed annually, resulting in 11,900 deaths
at an annual cost of $3.9 billion.73
In 2001, the top 50
medical and surgical procedures totaled approximately
41.8 million. These figures were taken from the
Healthcare Cost and Utilization Project within the
Agency for Healthcare Research and Quality.13 Using 17.6
percent from the 1974 U.S. Congressional House
Subcommittee Oversight Investigation as the percentage
of unnecessary surgical procedures, and extrapolating
from the death rate in 1974, we come up with an
unnecessary procedure number of 7.5 million (7,489,718)
and a death rate of 37,136, at a cost of $122 billion
(using 1974 dollars).
Researchers
performed a very similar analysis, using the 1974
‘unnecessary surgery percentage’ of 17.6, on back
surgery. In 1995, researchers testifying before the
Department of Veterans Affairs estimated that of 250,000
back surgeries in the U.S. at a hospital cost of $11,000
per patient, the total number of unnecessary back
surgeries each year in the U.S. could approach 44,000,
costing as much as $484 million.75
The unnecessary
surgery figures are escalating just as prescription
drugs driven by television advertising. Media-driven
surgery such as gastric bypass for obesity "modeled" by
Hollywood personalities seduces obese people to think
this route is safe and sexy. There is even a problem of
surgery being advertised on the Internet.76 A study in
Spain declares that between 20 percent and 25 percent of
total surgical practice represents unnecessary
operations.77
According to data
from the National Center for Health Statistics from 1979
to 1984, there was a nine percent increase in the total
number of surgical procedures, and the number of
surgeons grew by 20 percent. The author notes that there
has not been a parallel increase in the number of
surgeries despite a recent large increase in the number
of surgeons. There was concern that there would be too
many surgeons to share a small surgical caseload.78
The previous author
spoke too soon--there was no cause to worry about a
small surgical caseload. By 1994, there was an increase
of 38 percent for a total of 7,929,000 cases for the top
ten surgical procedures. In 1983, surgical cases totaled
5,731,000. In 1994, cataract surgery was number one with
over two million operations, and second was Cesarean
section (858,000 procedures). Inguinal hernia operations
were third (689,000 procedures), and knee arthroscopy,
in seventh place, grew 153 percent (632,000 procedures)
while prostate surgery declined 29 percent (229,000
procedures).79
The list of
iatrogenic diseases from surgery is as long as the list
of procedures themselves. In one study epidural
catheters were inserted to deliver anesthetic into the
epidural space around the spinal nerves to block them
for lower Cesarean section, abdominal surgery, or
prostate surgery. In some cases, non-sterile technique,
during catheter insertion, resulted in serious
infections, even leading to limb paralysis.80
In one review of the
literature, the authors demonstrated "a significant rate
of overutilization of coronary angiography, coronary
artery surgery, cardiac pacemaker insertion, upper
gastrointestinal endoscopies, carotid endarterectomies,
back surgery, and pain-relieving procedures."81
A 1987 JAMA study
found the following significant levels of inappropriate
surgery: 17 percent of cases for coronary angiography,
32 percent for carotid endarterectomy, and 17 percent
for upper gastrointestinal tract endoscopy.82 Using the
Healthcare Cost and Utilization Project (HCUP)
statistics provided by the government for 2001, the
number of people getting upper gastrointestinal
endoscopy, which usually entails biopsy, was 697,675;
the number getting endarterectomy was 142,401; and the
number having coronary angiography was 719,949.13
Therefore, according to the JAMA study 17 percent, or
118,604 people had an unnecessary endoscopy procedure.
Endarterectomy occurred in 142,401 patients; potentially
32 percent or 45,568 did not need this procedure. And 17
percent of 719,949, or 122,391 people receiving coronary
angiography were subjected to this highly invasive
procedure unnecessarily. These are all forms of medical
iatrogenesis. |