By
Gary Null PhD, Carolyn Dean MD ND, Martin Feldman MD, Debora
Rasio MD, Dorothy Smith PhD
ABSTRACT
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:
-
In 16.4 million people, 2.1% chance of a serious adverse
drug reaction,1 (186,000)
-
In 16.4 million people, 5-6% chance of acquiring a nosocomial
infection,9 (489,500)
-
In16.4 million people, 4-36% chance of having an iatrogenic
injury in hospital (medical error and adverse drug reactions),16
(1.78 million)
-
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 cant 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
dont 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 cant
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 medicines Pandoras
box in his 1994 JAMA paper, "Error in Medicine".16
He began the paper by reminiscing about Florence Nightingales
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 Brennans "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 OHare 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".
Its 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 Leapes 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 patients 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 arent 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
didnt use it at all. Dr. Wild says this does not bode
well for the future. If doctors dont 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 Lazarous 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 Lazarous 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
couldnt 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
Todays marketing of mood-modifying drugs, such as Prozac
or Zoloft, makes them not only socially acceptable but almost
a necessity in todays 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 NBCs "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 childrens ear infections, are viral, and antibiotics
dont 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 wont. 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.
Its another level of iatrogenic disease that we are
unable to completely measure.58-67
Specific Drug Iatrogenesis: NSAIDs
Its 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 dont
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. Abels 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.
Abels 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 arent
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
Its 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.
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