DEATH BY MEDICINE
By Gary Null PhD, Carolyn Dean MD ND, Martin Feldman
MD, Debora Rasio MD, Dorothy Smith PhD
(c) 2003, All Rights Reserved
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
TABLES AND FIGURES (see Section on Statistical
Tables and Figures, below, for exposition)
ANNUAL PHYSICAL AND ECONOMIC COST OF
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 1994)16
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 (which may have a drug error overlap with Lazorou's
study), we could add another 216,000 deaths making a total of
999,936 deaths annually.
ANNUAL UNNECESSARY MEDICAL EVENTS
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
- In 16.4 million people, 5-6% chance of
acquiring a nosocomial infection,9
- In 16.4 million people, 4-36% chance of having
an iatrogenic injury in hospital (medical error and adverse drug
- In 16.4 million people, 17% chance of a
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
|Adverse Drug Reaction
|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
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, about 50,000 people per day.
We have added, cumulatively, figures from 13
references of annual iatrogenic deaths. However, there is invariably
some degree of overlap and double counting that can occur in
gathering non-finite statistics. Death numbers don't come with names
and birth dates to prevent duplication On the other hand, there are
many missing statistics. As we will show, only about 5 to 20% of
iatrogenic incidents are even recorded.16,24,25,33,34
And, our outpatient iatrogenic statistics112
only include drug-related events and not surgical cases, diagnostic
errors, or therapeutic mishaps.
We have also been conservative in our inclusion of
statistics that were not reported in peer review journals or by
government institutions. For example, on July 23, 2002, The Chicago
Tribune analyzed records from patient databases, court cases, 5,810
hospitals, as well as 75 federal and state agencies and found
103,000 cases of death due to hospital infections, 75% of which were
We do not include this figure but report the lower Weinstein figure
Another figure that we withheld, for lack of proper peer review was
The National Committee for Quality Assurance, September 2003 report
which found that at least 57,000 people die annually from lack of
proper care for commons diseases such as high blood pressure,
diabetes, or heart disease.153
Overlapping of statistics in Death by Medicine may
occur with the Institute of Medicine (IOM) paper that designates
"medical error" as including drugs, surgery, and unnecessary
Since we have also included other statistics on adverse drug
reactions, surgery and, unnecessary procedures, perhaps a much as
50% of the IOM number could be redundant. However, even taking away
half the 98,000 IOM number still leaves us with iatrogenic events as
the number one killer at 738,000 annual deaths.
Even greater numbers of iatrogenic deaths will
eventually come to light when all facets of health care delivery are
measured. Most iatrogenic statistics are derived from hospital-based
studies. However, health care is no longer typically relegated to
hospitals. Today, health care is shared by hospitals, outpatient
clinics, transitional care, long-term care, rehabilitative care,
home care, and private practitioners offices. In the current climate
of reducing health-care costs, the number of hospitals and the
length of patient stays are being slashed. These measures will
increase the number of patients shunted into outpatient, home care,
and long-term care and the iatrogenic morbidity and mortality will
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% of the Gross National Product, healthcare
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% and only up to 20% 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 6 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
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
Jonathan Quick, Director of Essential Drugs and
Medicines Policy for the World Health Organization 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 will now accept
biased journalists (those who accept money from drug companies)
because it is too difficult to find ones that 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% chance that the drug will be perceived as effective
whereas a non-drug company-funded study will show favorable results
50% 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
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% of hospital patients suffered iatrogenic injury, with a 20%
fatality rate. Steel in 1981 reported that 36% of hospitalized
patients experienced iatrogenesis with a 25% fatality rate and
adverse drug reactions were involved in 50% of the injuries. Bedell
in 1991 reported that 64% 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%
iatrogenic injury rate for patients with a 14% fatality rate. From
the 98,609 patients injured and the 14% 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 4%
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%, 20%, and 4%), he would have
come up with a 20% medical error rate. The number of fatalities that
he could have presented, using an average rate of injury and his 14%
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 35-40% 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% 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% 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% 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%
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% 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
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% of all adverse
events result in an incident report, and only 6% of adverse drug
events are identified properly. The authors learned that the
American College of Surgeons gives a very broad guess that surgical
incident reports routinely capture only 5-30% of adverse events. In
one surgical study only 20% 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
Standard medical pharmacology texts admit that
relatively few doctors ever report adverse drug reactions to 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
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 5% of the actual reactions
Dr. Jay Cohen, who has extensively researched adverse drug
reactions, comments that because only 5% 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
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%
- requiring hospitals to develop systems to avoid
medical errors: very effective 74%
- better training of health professionals: very
- using only doctors specially trained in
intensive care medicine on intensive care units: very effective
- requiring hospitals to report all serious
medical errors to a state agency: very effective 71%
- increasing the number of hospital nurses: very
- reducing the work hours of doctors-in-training
to avoid fatigue: very effective 66%
- encouraging hospitals to voluntarily report
serious medical errors to a state agency: very effective 62%
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.
A survey of a 1992 national pharmacy database
found a total of 429,827 medication errors from 1,081 hospitals.
Medication errors occurred in 5.22% of patients admitted to these
hospitals each year. The authors concluded that a minimum of 90,895
patients annually were harmed by medication errors in the country as
A 2002 study shows that 20% of hospital
medications for patients had dosage mistakes. Nearly 40% 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%, 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 four hundred
patients after discharge from a tertiary care hospital (hospital
care that requires highly specialized skills, technology, or support
services). Seventy-six patients (19%) had adverse events. Adverse
drug events were the most common at 66%. The next most common events
were procedure-related injuries at 17%.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
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 5% of hospital admissions - over
1 million per year - are the result of drug side effects. But most
of the cases are not documented as such. The study found 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
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.
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% 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%) 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,
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
The leading causes of adverse drug reactions are
antibiotics (17%), cardiovascular drugs (17%), chemotherapy (15%),
and analgesics and anti-inflammatory agents (15%).49
Specific Drug Iatrogenesis: Antibiotics
Egger says overuse of antibiotics results in
food-borne infections resistant to antibiotics. Salmonella is found
in 20% of ground meat but constant exposure of cattle to antibiotics
has made 84% of salmonella resistant to at least one anti-salmonella
antibiotic. Diseased animal food accounts for 80% of salmonellosis
in humans, or 1.4 million cases per year. The conventional approach
to 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% 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 U.S. still receive antibiotics from their
According to the CDC, 90% of upper respiratory infections are viral
and should not be treated with antibiotics. In Germany the
prevalence for systemic antibiotic use in children aged 0-6 years
Data taken from nine U.S. health plans between
1996-2000 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%, from 2.46 to 1.89 antibiotic
prescriptions per/patient per/year. For children, 3 years to under 6
years, there was a 25% reduction from 1.47 to 1.09 antibiotic
prescriptions per/patient per/year. And for children aged 6 to under
18 years, there was a 16% reduction from 0.85 to 0.69 antibiotic
prescriptions per/ patient /per year.53
Although there was a reduction in antibiotic use, the data indicate
that on average every child in America receives 1.22 antibiotic
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%
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 U.S. Antibiotics were used in 73% of visits.
Furthermore, patients treated with antibiotics were given
non-recommended broad-spectrum antibiotics in 68% 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
If antibiotics were given in 73% of visits and should have only been
given in 10%, this represents 63%, or a total of 4.2 million visits
for sore throat that ended in unnecessary antibiotic prescriptions
between1989-1999. 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
On September 17, 2003 the CDC relaunched a
program, started in 1995, called "Get Smart: Know When Antibiotics
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% of upper respiratory
infections, including children's ear infections, are viral, and
antibiotics don't treat viral infection. More than 40% 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 1072 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
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
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
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
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
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 dollar fine to the
FDA for quality-control problems at four of its factories.72
The FDA tabulated infractions that included 90%, or 125 of the drugs
they made since 1998. Besides the fine, the company had to stop
drugs or suffer another $175 million dollar 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
1974: 2.4 million unnecessary surgeries performed
annually resulting in 11,900 deaths at an annual cost of $3.9
2001: 7.5 million unnecessary surgical procedures
resulting in 37,136 deaths at a cost of $122 billion (using 1974
It's very difficult to obtain accurate statistics
when studying unnecessary surgery. Dr. Leape in 1989 wrote that
perhaps 30% of controversial surgeries are unnecessary.
Controversial surgeries include Cesarean section, tonsillectomy,
appendectomy, hysterectomy, gastrectomy for obesity, breast
implants, and elective breast implants.74
Almost thirty years ago, in 1974, the
Congressional Committee on Interstate and Foreign Commerce held
hearings on unnecessary surgery. They found that 17.6% 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% 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
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 and 25% 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 9% increase in the
total number of surgical procedures, and the number of surgeons grew
by 20%. 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% 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% (632,000 procedures) while
prostate surgery declined 29% (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% of cases for coronary
angiography, 32% for carotid endarterectomy, and 17% 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%, or 118,604 people had an
unnecessary endoscopy procedure. Endarterectomy occurred in 142,401
patients; potentially 32% or 45,568 did not need this procedure. And
17% 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.
MEDICAL AND SURGICAL PROCEDURES
It is instructive to know the mortality rate
associated with different medical and surgical procedures. Even
though we must sign release forms when we undergo any procedure,
many of us are in denial about the true risks involved. We seem to
hold a collective impression that since medical and surgical
procedures are so commonplace, they are both necessary and safe.
Unfortunately, partaking in allopathic medicine itself is one of the
highest causes of death as well as the most expensive way to die.
Shouldn't the daily death rate of iatrogenesis in
hospitals, out of hospitals, in nursing homes, and psychiatric
residences be reported like the pollen count or the smog index?
Let's stop hiding the truth from ourselves. It's only when we focus
on the problem and ask the right questions can we hope to find
Perhaps the word "healthcare" gives us the
illusion that medicine is about health. Allopathic medicine is not a
purveyor of healthcare but of disease-care. Studying the mortality
figures in the Healthcare Cost and Utilization Project (HCUP) within
the U.S. government's Agency for Healthcare Research and Quality, we
found many points of interest.13
The HCUP computer program that calculates the annual mortality
statistics for all U.S. hospital discharges is only as good as the
codes that are put into the system. In an email correspondence with
HCUP, we were told that the mortality rates that were indicated in
tables and charts for each procedure were not necessarily due to the
procedure but only indicated that someone who received that
procedure died either from their original disease or from the
Therefore there is no way of knowing exactly how
many people died from a particular procedure. There are also no
codes for adverse drug side effects, none for surgical mishap, and
none for medical error. Until there are codes for medical error,
statistics of those people who are dying from various types of
medical error will be buried in the general statistics. There is a
code for "poisoning & toxic effects of drugs" and a code for
"complications of treatment." However, the mortality figures
registered in these categories are very low and don't compare with
what we know from studies such as the JAMA 1998 study1
that said there were an average of 106,000 prescription medication
deaths per year.
WHY AREN'T MEDICAL AND SURGICAL PROCEDURES STUDIED?
In 1978, the U.S. Office of Technology Assessment
(OTA) reported that, "Only 10%-20% of all procedures currently used
in medical practice have been shown to be efficacious by controlled
1995, the OTA compared medical technology in eight countries
(Australia, Canada, France, Germany, Netherlands, Sweden, United
Kingdom, and the United States) and again noted that few medical
procedures in the U.S. had been subjected to clinical trial. It also
reported that infant mortality was high and life expectancy was low
compared to other developed countries.84
Although almost ten years old, much of what was said in this report
holds true today. The report lays the blame for the high cost of
medicine squarely at the feet of the medical free-enterprise system
and the fact that there is no national health care policy. It
describes the failure of government attempts to control health care
costs due to market incentive and profit motive in the financing and
organization of health care including private insurance, hospital
system, physician services, and drug and medical device industries.
Whereas we may want to expand health-care, expansion of disease-care
is the goal of free enterprise. "Health Care Technology and Its
Assessment in Eight Countries" is also the last report prepared by
the OTA, which was shut down in 1995. It's also, perhaps, the last
honest, in-depth look at modern medicine. Because of the importance
of this 60-page report, we enclose a summary in the Appendix.
SURGICAL ERRORS FINALLY REPORTED
Just hours before completion of this paper,
statistics on surgical-related deaths became available. A October 8,
2003 JAMA study from the U.S. government's Agency for Healthcare
Research and Quality (AHRQ) documented 32,000 mostly surgery-related
deaths costing $9 billion and accounting for 2.4 million extra days
in the hospital in 2000.85
In a press release accompanying the JAMA study, the AHRQ director,
Carolyn M. Clancy, M.D., admitted, "This study gives us the first
direct evidence that medical injuries pose a real threat to the
American public and increase the costs of health care."86
Hospital administrative data from 20% of the nation's hospitals were
analyzed for eighteen different surgical complications including
postoperative infections, foreign objects left in wounds, surgical
wounds reopening, and post-operative bleeding. In the same press
release the study's authors said that, "The findings greatly
underestimate the problem, since many other complications happen
that are not listed in hospital administrative data." They also felt
that, "The message here is that medical injuries can have a
devastating impact on the health care system. We need more research
to identify why these injuries occur and find ways to prevent them
from happening." One of the authors, Dr. Zhan said that improved
medical practices, including an emphasis on better hand-washing,
might help reduce the morbidity and mortality rates. An accompanying
JAMA editorial by health-risk researcher Dr. Saul Weingart of
Harvard's Beth Israel Deaconess Medical Center said, "Given their
staggering magnitude, these estimates are clearly sobering."87
When X-rays were discovered, no one knew the
long-term effects of ionizing radiation. In the 1950's monthly
fluoroscopic exams at the doctor's office were routine. You could
even walk into most shoe stores and see your foot bones; looking at
bones was an amusing novelty. We still don't know the ultimate
outcome of our initial escapade with X-rays.
It was common practice to use X-rays in pregnant
women to measure the size of the pelvis, and make a diagnosis of
twins. Finally, a study of 700,000 children born between 1947 and
1964 was conducted in thirty-seven major maternity hospitals. The
children of mothers who had received pelvic X-rays during pregnancy
were compared with the children of mothers who had not been X-rayed.
Cancer mortality was 40% higher among the children with X-rayed
In present-day medicine, coronary angiography
combines an invasive surgical procedure of snaking a tube through a
blood vessel in the groin up to the heart. To get any useful
information during the angiography procedure X-rays are taken almost
continuously with minimum dosage ranges between 460 - 1,580 mrem.
The minimum radiation from a routine chest X-ray is 2 mrem. X-ray
radiation accumulates in the body and it is well-known that ionizing
radiation used in X-ray procedures causes gene mutation. We can only
obtain guesstimates as to its impact on health from this high level
of radiation. Experts manage to obscure the real effects in
statistical jargon such as, "The risk for lifetime fatal cancer due
to radiation exposure is estimated to be 4 in one million per 1,000
However, Dr. John Gofman, who has been studying
the effects of radiation on human health for 45 years, is prepared
to tell us exactly what diagnostic X-rays are doing to our health.
Dr. Gofman has a PhD in nuclear and physical chemistry and is a
medical doctor. He worked on the Manhattan nuclear project,
discovered uranium-2323, was the first person to isolate plutonium,
and since 1960, he's been studying the effects of radiation on human
health. With five scientifically documented books totaling over 2800
pages, Dr. Gofman provides strong evidence that medical technology,
specifically X-rays, CT scans, mammography, and fluoroscopy, are a
contributing factor to 75% of new cancers. His 699-page report,
updated in 2000, "Radiation from Medical Procedures in the
Pathogenesis of Cancer and Ischemic Heart Disease: Dose-Response
Studies with Physicians per 100,000 Population"90
shows that as the number of physicians increases in a geographical
area with an increase in the number of X-ray diagnostic tests, there
is an associated increase in the rate of cancer and ischemic heart
disease. Dr. Gofman elaborates that it's not X-rays alone that cause
the damage but a combination of health risk factors including: poor
diet, smoking, abortions, and the use of birth control pills. Dr.
Gofman predicts that 100 million premature deaths over the next
decade will be the result of ionizing radiation.
In his book, "Preventing Breast Cancer," Dr.
Gofman says that breast cancer is the leading cause of death among
American women between the ages of forty-four and fifty-five.
Because breast tissue is highly radiation-sensitive, mammograms can
cause cancer. The danger can be heightened by a woman's genetic
makeup, preexisting benign breast disease, artificial menopause,
obesity, and hormonal imbalance.91
Even X-rays for back pain can lead someone into
crippling surgery. Dr. Sarno, a well-known New York orthopedic
surgeon, found that X-rays don't always tell the truth. In his books
he cites studies on normal people without a trace of back pain that
have spinal abnormalities on X-ray. Other studies have shown that
some people with back pain have normal spines on X-ray. So, Dr.
Sarno says there is not necessarily any association between back
pain and spinal X-ray abnormality.92
However, if a person happens to have back pain and an incidental
abnormality on X-ray, they may be treated surgically, sometimes with
no change in back pain, or worsening of back pain, or even permanent
In addition, doctors often order X-rays as
protection against malpractice claims to give the impression that
they are leaving no stone unturned. It appears that doctors are
putting their own fears before the interests of their patients.
8.9 million (8,925,033) people were hospitalized
unnecessarily in 2001.4
In a study of inappropriate hospitalization 1,132
medical records were reviewed by two doctors. Twenty-three percent
of all admissions were inappropriate and an additional 17% could
have been handled in ambulatory out-patient clinics. Thirty-four
percent of all hospital days were also inappropriate and could have
The rate of inappropriate admissions in 1990 was 23.5%.94
In 1999, another study confirmed the figure of 24% inappropriate
admissions indicating a consistent pattern from 1986 to 1999,95
showing steady reporting of approximately 24% inappropriate
admissions each year. Putting these figures into present-day terms
using the HCUP database, the total number of patient discharges from
hospitals in the U.S. in 2001 was 37,187,641.13
The above data indicate that 24% of those hospitalizations need
never have occurred. It further means that 8,925,033 people were
exposed to unnecessary medical intervention in hospitals and
therefore represent almost 9 million potential iatrogenic episodes.4
WOMEN'S EXPERIENCE IN MEDICINE
Briefly, we will look at the medical iatrogenesis
of women in particular. Dr. Martin Charcot (1825-1893) was
world-renowned, the most celebrated doctor of his time. He practiced
in the Paris hospital La Salpetriere. He became an expert in
hysteria diagnosing an average of ten hysterical women each day,
transforming them into... "iatrogenic monsters," turning simple
'neurosis' into hysteria.96
The number of women diagnosed with hysteria and hospitalized rose
from 1% in 1841 to 17% in 1883. Hysteria is derived from the Latin
"hystera" meaning uterus. Dr. Adriane Fugh-Berman stated very
clearly in her paper that there is a tradition in U.S. medicine of
excessive medical and surgical interventions on women. Only one
hundred years ago male doctors decided that female psychological
imbalance originated in the uterus. When surgery to remove the
uterus was perfected it became the "cure" for mental instability,
effecting a physical and psychological castration. Dr. Fugh-Berman
noted that U.S. doctors eventually disabused themselves of that
notion but have continued to treat women very differently than they
She cites the following:
We would add that as many as one-third of
postmenopausal women use HRT.101, 102
These numbers are important in light of the much-publicized Women's
Health Initiative Study, which was forced to stop before its
completion because of a higher death rate in the synthetic
estrogen-progestin (HRT) group. 103
- Thousands of prophylactic mastectomies are
- One-third of U.S. women have had a hysterectomy
- Women are prescribed drugs more frequently than
- Women are given potent drugs for disease
prevention, which results in disease substitution due to side
- Fetal monitoring is unsupported by studies and
not recommended by the CDC.98
It confines women to a hospital bed and may result in higher
incidence of Cesarean section.99
- Normal processes such as menopause and
childbirth have been heavily medicalized.
- Synthetic hormone replacement therapy (HRT)
does not prevent heart disease or dementia. It does increase the
risk of breast cancer, heart disease, stroke, and gall bladder
In 1983, 809,000 Cesarean sections (21% of live
births) were performed, making it the most common obstetric and
gynecologic (OB/GYN) surgical procedure. The second most common
OB/GYN operation was hysterectomy (673,000), and diagnostic dilation
and curettage of the uterus (632,000) was third. In 1983, OB/GYN
operations represented 23% of all surgery completed in this country.
In 2001, Cesarean section is still the most common
OB/GYN surgical procedure. Approximately 4 million births occur
annually, with a 24% C-Section rate, i.e., 960,000 operations. In
the Netherlands only 8% of babies are delivered by Cesarean section.
Assuming human babies are similar in the U.S. and in the
Netherlands, we are performing 640,000 unnecessary C-Sections in the
U.S. with its three to four times higher mortality and 20 times
greater morbidity than vaginal delivery.
The Cesarean section rate was only 4.5% in the
U.S. in 1965. By 1986 it had climbed to 24.1%. The author states
that obviously an "uncontrolled pandemic of medically unnecessary
Cesarean births is occurring."106
VanHam reported a Cesarean section postpartum hemorrhage rate of 7%,
a hematoma formation rate of 3.5%, a urinary tract infection rate of
3%, and a combined postoperative morbidity rate of 35.7% in a
high-risk population undergoing Cesarean section.
The greatest cause of morbidity in vaginal births
is anorectal tearing. In a study of 20,500 women, 5% required an
episiotomy and 67 patients (.0033%) experienced wound disruption
that required surgical correction resulting in a "satisfactory
NEVER ENOUGH STUDIES
Scientists used the excuse that there were never
enough studies revealing the dangers of DDT and other dangerous
pesticides to ban them. They also used this excuse around the issue
of tobacco, claiming that more studies were needed before they could
be certain that tobacco really caused lung cancer. Even the American
Medical Association (AMA) was complicit in suppressing results of
tobacco research. In 1964, the Surgeon General's report condemned
smoking, however the AMA refused to endorse it. What was their
reason? They needed more research. Actually what they really wanted
was more money and they got it from a consortium of tobacco
companies who paid the AMA $18 million over the next nine years,
during which the AMA said nothing about the dangers of smoking.
The Journal of the American Medical Association
(JAMA), "after careful consideration of the extent to which
cigarettes were used by physicians in practice," began accepting
tobacco advertisements and money in 1933. State journals such as the
New York State Journal of Medicine also began to run Chesterfield
ads claiming that cigarettes are, "Just as pure as the water you
drink... and practically untouched by human hands." In 1948, JAMA
argued "more can be said in behalf of smoking as a form of escape
from tension than against it... there does not seem to be any
preponderance of evidence that would indicate the abolition of the
use of tobacco as a substance contrary to the public health."109
Today, scientists continue to use the excuse that they need more
studies before they will lend their support to restrict the
inordinate use of drugs.
OVERVIEW OF STATISTICAL TABLES AND FIGURES
Adverse Drug Reactions The Lazarou study1,
was based on statistical analysis of 33 million U.S. hospital
admissions in 1994. Hospital records for prescribed medications were
analyzed. The number of serious injuries due to prescribed drugs was
2.2 million; 2.1% of in-patients experienced a serious adverse drug
reaction; 4.7% of all hospital admissions were due to a serious
adverse drug reaction; and fatal adverse drug reactions occurred in
0.19% of in-patients and 0.13% of admissions. The authors concluded
that a projected 106,000 deaths occur annually due to adverse drug
We used a cost analysis from a 2000 study in which
the increase in hospitalization costs per patient suffering an
adverse drug reaction was $5,483. Therefore, costs for the Lazarou
study's 2.2 million patients with serious drug reactions amounted to
$12 billion. 1, 49
Serious adverse drug reactions commonly emerge
after Food and Drug Administration approval. The safety of new
agents cannot be known with certainty until a drug has been on the
market for many years. 110
Over one million people develop bedsores in U.S.
hospitals every year. It's a tremendous burden to patients and
family, and a $55 billion dollar healthcare burden.7
Bedsores are preventable with proper nursing care. It is true that
50% of those affected are in a vulnerable age group of over 70. In
the elderly bedsores carry a fourfold increase in the rate of death.
The mortality rate in hospitals for patients with bedsores is
between 23% and 37%.8
Even if we just take the 50% of people over 70 with bedsores and the
lowest mortality at 23%, that gives us a death rate due to bedsores
of 115,000. Critics will say that it was the disease or advanced age
that killed the patient, not the bedsore, but our argument is that
an early death, by denying proper care, deserves to be counted. It
is only after counting these unnecessary deaths that we can then
turn our attention to fixing the problem.
Malnutrition in Nursing Homes
The General Accounting Office (GAO), a special
investigative branch of Congress, gave citations to 20% of the
nation's 17,000 nursing homes for violations between July 2000 and
January 2002. Many violations involved serious physical injury and
A report from the Coalition for Nursing Home
Reform states that at least one-third of the nation's 1.6 million
nursing home residents may suffer from malnutrition and dehydration,
which hastens their death. The report calls for adequate nursing
staff to help feed patients who aren't able to manage a food tray by
It is difficult to place a mortality rate on malnutrition and
dehydration. This Coalition report states that malnourished
residents, compared with well-nourished hospitalized nursing home
residents, have a five-fold increase in mortality when they are
admitted to hospital. So, if we take one-third of the 1.6 million
nursing home residents who are malnourished and multiply that by a
mortality rate of 20%,8, 14
we find 108,800 premature deaths due to malnutrition in nursing
The rate of nosocomial infections per 1,000
patient days has increased 36% - from 7.2 in 1975 to 9.8 in 1995.
Reports from more than 270 U.S. hospitals showed that the nosocomial
infection rate itself had remained stable over the previous 20 years
with approximately five to six hospital-acquired infections
occurring per 100 admissions, which is a rate of 5-6%. However,
because of progressively shorter inpatient stays and the increasing
number of admissions, the actual number of infections increased. It
is estimated that in 1995, nosocomial infections cost $4.5 billion
and contributed to more than 88,000 deaths - one death every 6
2003 incidence of nosocomial mortality is quite probably higher than
in 1995 because of the tremendous increase in antibiotic-resistant
organisms. Morbidity and Mortality Report found that nosocomial
infections cost $5 billion annually in 1999.10
This is a $0.5 billion increase in four years. The present cost of
nosocomial infections might now be in the order of $5.5 billion.
Dr. Barbara Starfield in a 2000 JAMA paper
presents us with well-documented facts that are both shocking and
Dr. Starfield warns that one cause of medical
mistakes is the overuse of technology, which may create a "cascade
effect" leading to more treatment. She urges the use of ICD
(International Classification of Diseases) codes which have
designations called: "Drugs, Medicinal, and Biological Substances
Causing Adverse Effects in Therapeutic Use" and "Complications of
Surgical and Medical Care" to help doctors quantify and recognize
the magnitude of the medical error problem. Starfield says that, at
present, deaths actually due to medical error are likely to be coded
according to some other cause of death.
- The U.S. ranks twelfth out of 13 countries in a
total of 16 health indicators. Japan, Sweden, and Canada were
first, second, and third.
- More than 40 million people have no health
- 20% to 30% of patients receive contraindicated
She concludes that against the backdrop of our
abysmal health report card compared to the rest of the Westernized
countries, we should recognize that the harmful effects of health
care interventions account for a substantial proportion of our
Starfield cites Weingart's 2000 paper,
"Epidemiology of Medical Error" on outpatient iatrogenesis. And
Weingart, in turn, cites Johnson and Bootman, who asked pharmacists
to estimate the probability of adverse outcomes occurring as a
result of outpatient drug treatment. Statistics showed that between
4% and 18% of consecutive patients in outpatient settings suffer an
iatrogenic event leading to:112
- 116 million extra physician visits
- 77 million extra prescriptions
- 17 million emergency department visits
- 8 million hospitalizations
- 3 million long-term admissions
- 199,000 additional deaths
- $77 billion in extra costs
IT'S A GLOBAL ISSUE
A survey published in the Journal of Health
Affairs pointed out that between 18% and 28% of people who were
recently ill had suffered from a medical or drug error in the
previous two years. The study surveyed 750 recently-ill adults in
five different countries. The breakdown by country showed 18% of
those in Britain, 25% in Canada, 23% in Australia, 23% in New
Zealand, and the highest number was in the U.S. at 28%.113
A recent finding by the Institute of Medicine is
that the 41 million Americans without health insurance have
consistently worse clinical outcomes than those that are insured,
and are at increased risk for dying prematurely.
When doctors bill for services they do not render,
advise unnecessary tests, or screen everyone for a rare condition,
they are committing insurance fraud. The U.S. General Accounting
Office (GAO) gave a 1998 figure of $12 billion dollars lost to
fraudulent or unnecessary claims, and reclaimed $480 million in
judgments in that year. In 2001, the Federal government won or
negotiated more than $1.7 billion in judgments, settlements, and
administrative impositions in healthcare fraud cases and
WAREHOUSING OUR ELDERS
It is only fitting that we end this report with
acknowledgement of our elders. The moral and ethical fiber of
society can be judged by the way it treats its weakest and most
vulnerable members. Some cultures honor and respect the wisdom of
their elders, keeping them at home - the better to continue
participation in their community. However, American nursing homes,
where millions of our elders die, represent the pinnacle of social
isolation and medical abuse.
Important Statistics about Nursing Homes
Congressman Waxman reminded us that "as a society we
will be judged by how we treat the elderly" when he presented a
report that he sponsored, "Abuse of Residents is a Major Problem in
U.S. Nursing Homes," on July 30, 2001. The report uncovered that one
third - 5,283 of the nations' 17,000 nursing homes - were cited for
an abuse violation in the two-year period studied, January 1999 -
Waxman stated that "the people who cared for us, deserve better." He
also made it very clear that this was only the tip of the iceberg
and there is much more abuse occurring that we don't know about or
The major findings of "Abuse of Residents is a Major Problem in U.S.
Nursing Homes," were:
- In America, at any one time, approximately 1.6
million elderly are confined to nursing homes. By 2050 that number
could be 6.6 million.11, 116
- A total of 20% of all deaths from all causes
occur in nursing homes.117
- Hip fractures are the single greatest reason
for nursing home admissions.118
Nursing homes represent a reservoir for drug-resistant organisms
due to overuse of antibiotics.119
Dangerously understaffed nursing homes lead to
neglect, abuse, overuse of medications, and physical restraints. An
exhaustive study of nurse-to-patient ratios in nursing homes was
mandated by Congress in 1990. The study was finally begun in 1998
and took four years to complete.120
Commenting on the study, a spokesperson for The National Citizens'
Coalition for Nursing Home Reform said, "They compiled two reports
of three volumes each thoroughly documenting the number of hours of
care residents must receive from nurses and nursing assistants to
avoid painful, even dangerous, conditions such as bedsores and
infections. Yet it took the Department of Health and Human Services
and Secretary Tommy Thompson only four months to dismiss the report
Bedsores occur three times more commonly in nursing homes than in
acute care or veterans' hospitals.122
But we know that bedsores can be prevented with proper nursing care.
It shouldn't take four years for someone to find out that proper
care of bedsores requires proper staffing. In spite of such urgent
need in nursing homes where additional staff could solve so many
problems, we hear the familiar refrain "not enough research" - one
that merely buys time for those in charge and relegates another
smoldering crisis to the back burner.
- Over 30% of nursing homes in the U.S. were
cited for abuses, totaling more than 9,000 abuse violations.
- 10% of nursing homes had violations that caused
actual physical harm to residents, or worse.
- Over 40%, or 3,800 abuse violations were only
discovered after a formal complaint was filed, usually by
concerned family members.
- Many verbal abuse violations were found.
- Occasions of sexual abuse.
- Incidents of physical abuse causing numerous
injuries such as fractured femur, hip, elbow, wrist, and other
Since many nursing home patients suffer from
chronic debilitating conditions, their assumed cause of death is
often unquestioned by physicians. Some studies show that as many as
50% of deaths due to restraints, falls, suicide, homicide, and
choking in nursing homes may be covered up.123,
124 It is quite possible that many
nursing home deaths are attributed, instead, to heart disease,
which, until our report, was the number one cause of death. In fact,
researchers have found that heart disease may be over-represented in
the general population as a cause of death on death certificates by
7.9% to 24.3%. In the elderly the over-reporting of heart disease as
a cause of death is as much as two-fold.125
When elucidating iatrogenesis in nursing homes,
some critics have asked, "To what extent did these elderly people
already have life-threatening diseases that led to their premature
deaths anyway?" Our response is that if a loved one dies one day,
one week, one year, a decade, or two decades prematurely, thanks to
some medical misadventure, that is still a premature, iatrogenic
death. In a legalistic sense perhaps more weight is placed on the
loss of many potential years compared to an additional few weeks,
but this attitude is not justified in an ethical or moral sense.
The fact that there are very few statistics on
malnutrition in acute-care hospitals and nursing homes shows the
lack of concern in this area. A survey of the literature turns up
very few American studies. Those that do appear are foreign studies
in Italy, Spain, and Brazil. However, there is one very revealing
American study conducted over a 14-month period that evaluated 837
patients in a 100-bed sub-acute-care hospital for their nutritional
status. Only 8% of the patients were found to be well nourished.
Almost one-third (29%) were malnourished and almost two-thirds (63%)
were at risk of malnutrition. The consequences of this state of
deficiency were that 25% of the malnourished patients required
readmission to an acute-care hospital compared to 11% of the
well-nourished patients. The authors concluded that malnutrition
reached epidemic proportions in patients admitted to this
sub-acute-care facility. 126
Many studies conclude that physical restraints are
an underreported and preventable cause of death. Whereas
administrators say they must use restraints to prevent falls, in
fact, they cause more injury and death because people naturally
fight against such imprisonment. Studies show that compared to no
restraints, the use of restraints carries a higher mortality rate
and economic burden.127-129
Studies found that physical restraints, including bedrails, are the
cause of at least 1 in every 1,000 nursing-home deaths.130-132
However, deaths caused by malnutrition,
dehydration, and physical restraints are rarely recorded on death
certificates. Several studies reveal that nearly half of the listed
causes of death on death certificates for older persons with chronic
or multi-system disease are inaccurate.133
Even though 1-in-5 people die in nursing homes, the autopsy rate is
Thus, we have no way of knowing the true causes of death.
The CDC may be focused on reducing the number of
prescriptions for children but a 2003 study finds over-medication of
our elderly population. Dr. Robert Epstein, chief medical officer of
Medco Health Solutions Inc. (a unit of Merck & Co.), conducted the
study on drug trends.135
He found that seniors are going to multiple physicians and getting
multiple prescriptions and using multiple pharmacies. Medco oversees
drug-benefit plans for more than 60 million Americans, including 6.3
million senior citizens who received more than 160 million
prescriptions. According to the study, the average senior receives
25 prescriptions annually. In those 6.3 million seniors, a total of
7.9 million medication alerts were triggered: less than one-half
that number, 3.4 million, were detected in 1999. About 2.2 million
of those alerts indicated excessive dosages unsuitable for senior
citizens, and about 2.4 million alerts indicated clinically
inappropriate drugs for the elderly. Reuters interviewed Kasey
Thompson, director of the Center on Patient Safety at the American
Society of Health System Pharmacists, who said, "There are serious
and systemic problems with poor continuity of care in the United
States." He says this study shows "the tip of the iceberg" of a
According to Drug Benefit Trends, the average
number of prescriptions dispensed per non-Medicare HMO member per
year rose 5.6% from 1999 to 2000 - from 7.1 to 7.5 prescriptions.
The average number dispensed for Medicare members increased 5.5% -
from 18.1 to 19.1 prescriptions.136
The number of prescriptions in 2000 was 2.98 billion, with an
average per person prescription amount of 10.4 annually.137
In a study of 818 residents of residential care
facilities for the elderly, 94% were receiving at least one
medication at the time of the interview. The average intake of
medications was five per resident; the authors noted that many of
these drugs were given without a documented diagnosis justifying
Unfortunately, seniors, and groups like the
American Association for Retired Persons (AARP), appear to be
dependent on prescription drugs and are demanding that coverage for
drugs be a basic right.139
They have accepted the overriding assumption from allopathic
medicine that aging and dying in America must be accompanied by
drugs in nursing homes and eventual hospitalization with tubes
coming out of every orifice. Instead of choosing between drugs and a
diet-lifestyle change, seniors are given the choiceless option of
either high-cost patented drugs or low-cost generic drugs. Drug
companies are attempting to keep the most expensive drugs on the
shelves and to suppress access to generic drugs, in spite of stiff
fines of hundreds of millions of dollars from the government.140,
141 In 2001 some of the world's biggest
drug companies, including Roche, were fined a record £523 million
($871 million) for conspiring to increase the price of vitamins.142
We would urge AARP, especially, to become more
involved in prevention of disease and not to rely so heavily on
drugs. At present, the AARP recommendations for diet and nutrition
assume that seniors are getting all the nutrition they need in an
average diet. At most, they suggest extra calcium and a multiple
This is not enough, and in our next report we will show how to live
a healthier life without unnecessary medical intervention.
We would like to send the same message to the
Hemlock Society, which offers euthanasia options to chronically ill
people, especially those in severe pain. What if some of these
chronic diseases are really lifestyle diseases caused by deficiency
of essential nutrients, lack of care, inappropriate medication, or
lack of love? This question is extremely important to consider when
you are depressed or in pain. We must look to healing those
conditions before offering up our lives.
Let's also look at the irony of under use of
proper pain medication for patients that really need it. For
example, in one particular study pain management was evaluated in a
group of 13,625 cancer patients, aged 65 or over, living in nursing
homes. Overall, almost 30%, or 4,003 patients, reported pain.
However, more than 25% received absolutely no pain relief
medication; 16% received a World Health Organization (WHO) level-one
drug (mild analgesic); 32% a WHO level-two drug (moderate
analgesic); and only 26% received adequate pain relieving morphine.
The authors concluded that older patients and minority patients were
more likely to have their pain untreated.
The time has come to set a standard for caring for
the vulnerable among us - a standard that goes beyond making sure
they are housed and fed, and not openly abused. We must stop looking
the other way and we, as a society, must take responsibility for the
way in which we deal with those who are unable to care for
WHAT REMAINS TO BE UNCOVERED
Our ongoing research will continue to quantify the
iatrogenic morbidity, mortality, and financial loss in outpatient
clinics, transitional care, long-term care, rehabilitative care,
home care, private practitioners offices, as well as hospitals, due
- X-ray exposures: mammography, fluoroscopy, CT
- Overuse of antibiotics in all conditions.
- Drugs that are carcinogenic: hormone
replacement therapy (*see below), immunosuppressive drugs,
- Cancer chemotherapy: If it doesn't extend life,
is it shortening life?70
- Surgery and surgical procedures.
- Unnecessary surgery: Cesarean section, radical
mastectomy, preventive mastectomy, radical hysterectomy,
prostatectomy, cholecystectomies, cosmetic surgery, arthroscopy,
- Medical procedures and therapies.
- Discredited, unnecessary, and unproven medical
procedures and therapies.
- Doctors themselves: when doctors go on strike,
it appears the mortality rate goes down.
- Missed diagnoses.
Results of the "Million Women Study" on HRT and
breast cancer in the U.K were published in the Lancet, August, 2003.
Lead author, Professor Valerie Beral, Director of the Cancer
Research UK Epidemiology Unit, is very open about the damage HRT has
caused. She said, "We estimate that over the past decade, use of HRT
by UK women aged 50-64 has resulted in an extra 20,000 breast
cancers, oestrogen-progestagen (combination) therapy accounting for
15,000 of these."151
However, we were not able to find the statistics on breast cancer,
stroke, uterine cancer, or heart disease due to HRT used by American
women. The population of America is roughly six times that of the
U.K. Therefore, it is possible that 120,000 cases of breast cancer
have been caused by HRT in the past decade.
- *Part of our ongoing research will be to
quantify the mortality and morbidity caused by hormone replacement
therapy (HRT) since the mid-1940's. In December 2000, a government
scientific advisory panel recommended that synthetic estrogen be
added to the nation's list of cancer-causing agents. HRT, either
synthetic estrogen alone or combined with synthetic progesterone,
is used by an estimated 13.5 to 16 million women in the U.S.145
The aborted Women's Health Initiative Study (WHI) of 2002 showed
that women taking synthetic estrogen combined with synthetic
progesterone have a higher incidence of ovarian cancer, breast
cancer, stroke, and heart disease and little evidence of
osteoporosis reduction or prevention of dementia. WHI researchers,
who usually never give recommendations, other than demanding more
studies, are advising doctors to be very cautious about
prescribing HRT to their patients.100,
When the number one killer in a society is the
healthcare system, then, that system has no excuse except to address
its own urgent shortcomings. It's a failed system in need of
immediate attention. What we have outlined in this paper are
insupportable aspects of our contemporary medical system that need
to be changed - beginning at its very foundations.
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OFFICE OF TECHNOLOGY ASSESSMENT (OTA)
Health Care Technology and Its Assessment in Eight Countries,
Shortly after this report, the OTA was
- In 1990 life expectancy in the U.S. was 71.8
years for men and 78.8 for women, among the lowest of the
- The 1990 infant mortality rate was 9.2 per
1,000 live births. This was in the bottom half of the distribution
among all developed countries. (OTA comments on the frustration of
poor statistics and high healthcare spending.)
- Health status is correlated with socioeconomic
- Healthcare is not universal.
- Healthcare is based on the free market system
with no fixed budget or limitations on expansion.
- Healthcare accounts for 14% of the U.S. GNP,
which was over $800 billion in 1993.
- The federal government does no central
planning. It is the major purchaser of health care for older
people and some poor people.
- Americans have a lower level of satisfaction
with their healthcare system than people in other developed
- U.S. medicine specializes in expensive medical
technology. Some major U.S. cities have more MRI scanners than
- Huge public and private investment in medical
research and pharmaceutical development drives this "technological
- Any efforts to restrain technological
developments in healthcare are opposed by policy makers concerned
about negative impacts on medical-technology industries.
- In 1990 there were: 5,480 acute-care hospitals,
880 specialty hospitals (psychiatric, long-term care, rehab) and
340 federal hospitals (military, vets and Native Americans)
providing 2.7 hospitals per 100,000 population.
- In 1990 the average length of stay for an
annual 33 million admissions was 9.2 days. Bed occupancy rate was
66%. Lengths of stay were shorter and admission rates lower than
- In 1990 there were 615,000 physicians, 2.4 per
1,000; 33% were primary care (family medicine, internal medicine,
and pediatrics) and 67% were specialists.
- In 1991 government-run healthcare spending was
- Total healthcare spending was $752 billion in
1991, an increase from $70 billion in 1950. Spending grew
five-fold per capita.
- Reasons for increased healthcare spending:
- A. The high cost of defensive medicine, with
an escalation in services solely to avoid malpractice
- B. U.S. healthcare based on defensive
medicine costs nearly $45 billion per year, or about 5% of total
healthcare spending, according to one source.
- C. The availability and use of new medical
technologies have contributed the most to increased healthcare
spending, argue many analysts. OTA admits that these costs are
impossible to quantify.
- The reasons government attempts to control
healthcare costs have failed:
Health-Related Research and Development
- A. Market incentive and profit-motive
involvement in the financing and organization of healthcare
including private insurance, hospital system, physician
services, and drug and medical device industries.
- B. Expansion is the goal of free enterprise.
- The U.S. spends more than any other country on
R & D.
- $9.2 billion was spent in 1989 by the federal
government; U.S. industries spent an additional $9.4 billion.
- There was a 50% rise in total national R & D
expenditures between 1983 and 1992.
- NIH receives about half of the government
- NIH spent more on basic research ($4.1 billion
in 1989) than for clinical trials of medical treatments on humans
($519 million in 1989).
- Most of the trials evaluate new cancer
treatment protocols and new treatments for complications of AIDS
and do not study existing treatments, even though the
effectiveness of many of them is unknown and questioned.
- The NIH in 1990 had just begun to do
meta-analysis and cost-effectiveness analysis.
Pharmaceutical and Medical Device
- About two-thirds of the industry's $9.4 billion
budget went to drug research; the remaining one-third was spent by
- In addition to R & D, the medical industry
spent 24% of total sales on promoting their products and only 15%
of total sales on development.
- Total marketing expenses in 1990 were over $5
- Many products provide no benefit over existing
- Public and private healthcare consumers buy
- If healthcare spending is perceived as a
problem, a highly profitable drug industry exacerbates the
Controlling Health Care Technology
- The FDA ensures the safety and efficacy of
drugs, biologics, and medical devices.
- The FDA does not consider costs of therapy.
- The FDA does not consider the effectiveness of
- The FDA does not compare a product to currently
- The FDA does not consider non-drug alternatives
for a given clinical problem.
- Drug development costs $200 million to bring a
new drug to market. AIDS-drug interest groups forced new
regulations that speed up the approval process.
- Such drugs should be subject to greater
post-marketing surveillance requirements. But as of 1995 these
provisions had not yet come into play.
- Many argue that reductions in the pre-approval
testing of drugs opens the possibility of significant undiscovered
Health Care Technology Assessment
- Failure to evaluate technology was a focus of a
1978 report from OTA with examples of many common medical
practices supported by limited published data. (10-20%)
- In 1978 congress created the National Center
for Health Care Technology (NCHCT) to advise Medicare and
- With an annual budget of $4 million NCHCT
published three broad assessments of high-priority technologies
and made about 75 coverage recommendations to Medicare.
- NCHCT was put out of business by Congress in
1981-a political casualty. The medical profession opposed it from
the beginning. The AMA testified before Congress in 1981 that
"clinical policy analysis and judgments are better made-and are
being responsibly made-within the medical profession. Assessing
risks and costs, as well as benefits, has been central to the
exercise of good medical judgment for decades."
- The medical device lobby also opposed
government oversight by NCHCT.
Examples of Lack of Proper Management of
I. Treatments for Coronary Artery Disease
- Since the early 1970's the number of coronary
artery-bypass surgeries (CABGS) has risen rapidly without
government regulation and without clinical trials.
- Angioplasty for single vessel disease was
introduced in 1978. The first published trial of angioplasty
versus medical treatment was in 1992.
- Angioplasty did not cut down on the number of
CABGS as was promoted.
- Both procedures increase in number every year
as the patient population grows older and sicker.
- Rates of use are higher in white patients, in
private insurance patients, and there is great variation in
different geographic regions. Such facts imply that use of these
procedures is based on non-clinical factors.
- At the time of this report, 1995, the NIH
consensus program had not assessed CABGS since 1980 and had never
- RAND researchers evaluated CABGS in New York in
1990. They reviewed 1,300 procedures and found 2% were
inappropriate, 90% appropriate, and 7% uncertain. For 1,300
angioplasties, 4% were inappropriate and 38% uncertain. Using RAND
methodologies a panel of British physicians rated twice as many
procedures "inappropriate" as did a U.S. panel rating the same
clinical cases. The New York numbers are in question because New
York State limits the number of surgery centers, and the
per-capita supply of cardiac surgeons in New York is about
one-half the national average.
- The estimated five-year cost is $33,000 for
angioplasty and $40,000 for CABGS. So, angioplasty did not lower
costs. This was because of high failure rates of angioplasty.
II. Computed Tomography CT
- The first CT scanner in the U.S. was installed
at the Mayo Clinic in 1973. In 1992 the number of operational CT
scanners was 6,060. By comparison, in 1993 there were 216 CT units
- There is little information available on how CT
scan improves or affects patient outcome.
- In some institutions up to 90% of scans
performed were negative.
- Approval by the FDA was not required for CT
scanners. No evidence of safety or efficacy was required.
- The first MRI was introduced in 1978 in Great
Britain; the first U.S. scanner in 1980. By 1988 there were 1,230
units; by 1992 between 2,800 and 3,000.
- A definitive review published in 1994 found
less than 30 studies out of 5,000 that were prospective
comparisons of diagnostic accuracy or therapeutic choice.
- American College of Physicians assessed MRI
studies and rated 13 out of 17 trials as "weak" - meaning the
absence of any studies on therapeutic impact or patient outcomes.
- The OAT concludes that, "It is evident that
hospitals, physician-entrepreneurs, and medical device
manufacturers have approached MRI and CT as commodities with
high-profit potential, and decision-making on the acquisition and
use of these procedures has been highly influenced by this
approach. Clinical evaluation, appropriate patient selection, and
matching supply to legitimate demand might be viewed as secondary
IV. Laparoscopic Surgery
- Laparoscopic cholecystectomy was introduced at
a professional surgical society meeting in late 1989. In 1992,
five years after introduction, 85% of all cholecystectomies were
- There was an associated increase of 30% in the
number of cholecystectomies performed.
- Because of the increased volume of gall bladder
operations, the total costs increased 11.4% between 1988 and 1992,
in spite of a 25.1% drop in the average cost per surgery.
- The mortality rate for gall bladder surgeries
also did not decline as a result of the lower risk because so many
more were performed.
- When studies were finally done on completed
cases, the results showed that laparoscopic cholecystectomy was
associated with reduced in-patient duration, decreased pain, and
shorter period of restricted activity. But there were increased
rates of bile duct and major vessel injuries and a suggestion that
these rates were worse for people with acute cholecystitis. There
were still no clinical trials to clarify this issue.
- Patient demand, fueled by substantial media
attention, was a major force in promoting rapid adoption.
- The video, which introduced the procedure in
1989, was produced by the major manufacturer of laparoscopic
- Doctors were given two-day training seminars
before performing the surgery on patients.
- In 1990 the U.S. ranked twenty-fourth in infant
mortality out of 38 developed countries with a rate of 9.2 deaths
per 1,000 live births.
- U.S. black infant mortality is 18.6 per 1,000
live births and 8.8 for whites.
Screening for Breast Cancer
- There has always been a debate over mammography
screening in women under 50.
- In 1992 the Canadian National Breast Cancer
Study of 50,000 women showed that mammography had no effect on
mortality for younger women, aged 40-50.
- The National Cancer Institute (NCI) refused to
change its recommendations on mammography.
- The American Cancer Society decided to wait for
more studies on mammography.
- Then, in December 1993 NCI announced that women
over 50 should have routine screening every one to two years but
younger women would have no benefit from having mammography.
- The OTA concluded that, "There are no
mechanisms in place to limit dissemination of technologies
regardless of their clinical value."