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Death by Medicine, Part I
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 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.
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