| |  |
I will be giving you a great
deal of important information in this area over the coming years, but
for now I want to give you an exceptional article with lots of Evidence
relating
to Medicine. The following article, entitled Death By Medicine, was written
as a collaborative effort by a number of MD's and PhD's. It is one of
the most provocative and well researched articles I have ever read, that
thoroughly exposes medical statistics that the public needs to know.
I was extremely
happy to be given the right to reproduce the entire article on my web
site.
The email that I received in response to my request for permission to
reproduce this article contained the following-
The article was based on original research
and writing that was sponsored by the Nutrition Institute of America,
Inc. (NIA) a not-for-profit 501(c)(3) corporation. NIA has no objection
to your publication and free dissemination of the article, but reserves
the right to revoke this permission with notice in writing.
So here it is. I suggest that you read
it, and have others read it. Knowledge is power.
Death by Medicine
By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio,
MD; and Dorothy Smith, PhD
Something is wrong when regulatory agencies
pretend that vitamins are dangerous, yet ignore published statistics showing
that government-sanctioned medicine is the real hazard.
Until now, Life Extension could cite only isolated
statistics to make its case about the dangers of conventional medicine.
No one had ever analyzed and combined ALL of the published literature dealing
with injuries and deaths caused by government-protected medicine. That
has now changed.
A group of researchers meticulously reviewed
the statistical evidence and their findings are absolutely shocking.4 These
researchers have authored a paper titled “Death by Medicine” that
presents compelling evidence that today’s system frequently causes
more harm than good.
This fully referenced report shows the number
of people having in-hospital, adverse reactions to prescribed drugs to
be 2.2 million per year. The number of unnecessary antibiotics prescribed
annually for viral infections is 20 million per year. The number of unnecessary
medical and surgical procedures performed annually is 7.5 million per year.
The number of people exposed to unnecessary hospitalization annually is
8.9 million per year.
The most stunning statistic, however, is that
the total number of deaths caused by conventional medicine is an astounding
783,936 per year. It is now evident that the American medical system is
the leading cause of death and injury in the US. (By contrast, the number
of deaths attributable to heart disease in 2001 was 699,697, while the
number of deaths attributable to cancer was 553,251.5)
Natural medicine is under siege, as pharmaceutical
company lobbyists urge lawmakers to deprive Americans of the benefits of
dietary supplements. Drug-company front groups have launched slanderous
media campaigns to discredit the value of healthy lifestyles. The FDA continues
to interfere with those who offer natural products that compete with prescription
drugs.
1. These attacks against natural medicine obscure
a lethal problem that until now was buried in thousands of pages of scientific
text. In response to these baseless challenges to natural medicine, the
Nutrition Institute of America commissioned an independent review of the
quality of “government-approved” medicine. The startling findings
from this meticulous study indicate that conventional medicine is “the
leading cause of death” in the United States.
The Nutrition Institute of America is a nonprofit
organization that has sponsored independent research for the past 30 years.
To support its bold claim that conventional medicine is America 's number-one
killer, the Nutritional Institute of America mandated that every “count” in
this “indictment” of US medicine be validated by published,
peer-reviewed scientific studies.
What you are about to read is a stunning compilation
of facts that documents that those who seek to abolish consumer access
to natural therapies are misleading the public. Over 700,000 Americans
die each year at the hands of government-sanctioned medicine, while the
FDA and other government agencies pretend to protect the public by harassing
those who offer safe alternatives.
A definitive review of medical peer-reviewed
journals and government health statistics shows that American medicine
frequently causes more harm than good.
Each year approximately 2.2 million US hospital
patients experience adverse drug reactions (ADRs) to prescribed medications.(1)
In 1995, Dr. Richard Besser of the federal Centers for Disease Control
and Prevention (CDC) estimated the number of unnecessary antibiotics prescribed
annually for viral infections to be 20 million; in 2003, Dr. Besser spoke
in terms of tens of millions of unnecessary antibiotics prescribed annually.(2,
2a) Approximately 7.5 million unnecessary medical and surgical procedures
are performed annually in the US,(3) while approximately 8.9 million Americans
are hospitalized unnecessarily.(4)
As shown in the following table, the estimated
total number of iatrogenic deaths—that is, deaths induced inadvertently
by a physician or surgeon or by medical treatment or diagnostic procedures— in
the US annually is 783,936. It is evident that the American medical system
is itself the leading cause of death and injury in the US. By comparison,
approximately 699,697 Americans died of heart in 2001, while 553,251 died
of cancer.(5)
Table 1: Estimated Annual Mortality and
Economic Cost
of Medical Intervention
|
| Condition |
Deaths |
Cost |
Author |
| Adverse Drug Reactions |
106,000 |
$12 billion |
Lazarou(1), Suh (49) |
| Medical error |
98,000 |
$2 billion |
IOM(6) |
| Bedsores |
115,000 |
$55 billion |
Xakellis(7), Barczak (8) |
| Infection |
88,000 |
$5 billion |
Weinstein(9), MMWR (10) |
| Malnutrition |
108,800 |
--------- |
Nurses Coalition(11) |
| Outpatients |
199,000 |
$77 billion |
Starfield(12), Weingart(112) |
| Unnecessary Procedures |
37,136 |
$122 billion |
HCUP(3,13) |
| Surgery-Related |
32,000 |
$9 billion |
AHRQ(85) |
| Total |
783,936 |
$282 billion |
|
Using Leape's 1997 medical and drug
error rate of 3 million(14) multiplied by the 14% fatality rate he used
in 1994(16) produces an annual death rate of 420,000 for drug errors and
medical errors combined. Using this number instead of Lazorou's 106,000
drug errors and the Institute of Medicine 's (IOM) estimated 98,000 annual
medical errors would add another 216,000 deaths, for a total of 999,936
deaths annually.
Table 2: Estimated Annual Mortality and
Economic Cost of Medical Intervention
|
| Condition |
Deaths |
Cost |
Author |
| ADR/med error |
420,000 |
$200 billion |
Leape(14) |
| Bedsores |
115,000 |
$55 billion |
Xakellis(7), Barczak (8) |
| Infection |
88,000 |
$5 billion |
Weinstein(9), MMWR (10) |
| Malnutrition |
108,800 |
--------- |
Nurses Coalition(11) |
| Outpatients |
199,000 |
$77 billion |
Starfield(12), Weingart(112) |
| Unnecessary Procedures |
37,136 |
$122 billion |
HCUP (3,13) |
| Surgery-Related |
32,000 |
$9 billion |
AHRQ(85) |
| Total |
999,936 |
|
|
The enumerating of unnecessary medical
events is very important in our analysis. Any invasive, unnecessary medical
procedure must be considered as part of the larger iatrogenic picture.
Unfortunately, cause and effect go unmonitored. The figures on unnecessary
events represent people who are thrust into a dangerous health care system.
Each of these 16.4 million lives is being affected in ways that could have
fatal consequences. Simply entering a hospital could result in the following:
| |
In 16.4 million people, a 2.1% chance (affecting
186,000) of a serious adverse drug reaction(1)
In 16.4 million people, a 5-6% chance (affecting 489,500) of acquiring a nosocomial
infection(9)
In 16.4 million people, a 4-36% chance (affecting 1.78 million) of having an
iatrogenic injury (medical error and adverse drug reactions).(16)
In 16.4 million people, a 17% chance (affecting 1.3 million) of a procedure error.(40) |
These statistics represent a one-year
time span. Working with the most conservative figures from our statistics,
we project the following 10-year death rates.
| Table 3: Estimated 10-Year Death Rates from Medical Intervention |
| Condition |
10-Year Deaths |
Author |
| Adverse Drug Reaction |
1.06 million |
(1) |
| Medical error |
0.98 million |
(6) |
| Bedsores |
1.15 million |
(7,8) |
| Nosocomial infection |
0.88 million |
(9,10) |
| Malnutrition |
1.09 million |
(11) |
| Outpatients |
1.99 million |
(12, 112) |
| Unnecessary Procedures |
371,360 |
(3,13) |
| Surgery-related |
320,000 |
(85) |
| Total |
7,841,360 |
|
Our estimated 10-year total of 7.8
million iatrogenic deaths is more than all the casualties from all the
wars fought by the US throughout its entire history.
Our projected figures for unnecessary medical
events occurring over a 10-year period also are dramatic.
| Table 4: Estimated 10-Year Unnecessary Medical Events |
| Unnecessary Events |
10-year Number |
Iatrogenic Events |
| Hospitalization |
89 million(4) |
17 million |
| Procedures |
75 million(3) |
15 million |
| Total |
164 million |
|
These figures show that an estimated
164 million people—more than half of the total US population—receive
unneeded medical treatment over the course of a decade.
INTRODUCTION
Never before have the complete statistics on the multiple causes of iatrogenesis
been combined in one article. Medical science amasses tens of thousands
of papers annually, each representing a tiny fragment of the whole picture.
To look at only one piece and try to understand the benefits and risks
is like standing an inch away from an elephant and trying to describe
everything about it. You have to step back to see the big picture, as
we have done
here. Each specialty, each division of medicine keeps its own records
and data on morbidity and mortality. We have now completed the painstaking
work of reviewing thousands of studies and putting pieces of the puzzle
together. Is American Medicine Working?
US health care spending reached $1.6 trillion in 2003, representing
14% of the nation's gross national product.(15) Considering this
enormous expenditure,
we should have the best medicine in the world. We should be preventing
and reversing disease, and doing minimal harm. Careful and objective
review, however, shows we are doing the opposite. Because of the
extraordinarily
narrow, technologically driven context in which contemporary medicine
examines the human condition, we are completely missing the larger
picture.
Medicine is not taking into consideration the following critically
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 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
spent on preventing disease.
Underreporting of Iatrogenic Events
As few as 5% and no more than 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 an annual iatrogenic death toll much higher
than 783,936.
In 1994, Leape said his figure of 180,000 medical mistakes resulting
in death
annually was equivalent to three jumbo-jet crashes every two days.(16)
Our considerably higher figure is equivalent to six jumbo jets are
falling out
of the sky each day.
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 obvious that we cannot
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 of what stands in the way of change: powerful
pharmaceutical and medical technology companies, along with other
powerful 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 new therapies
and drugs. You have
only to look
at the people who make up the hospital, medical, and government
health advisory boards to see conflicts of interest. The public
is mostly
unaware
of these
interlocking interests.
For example, a 2003 study found that nearly half of medical school
faculty who serve on institutional review boards (IRB) to advise
on clinical
trial research also serve as consultants to the pharmaceutical
industry.(17) The study authors were concerned that such representation
could cause
potential
conflicts of interest. A news release by Dr. Erik Campbell,
the lead author, said, "Our previous research with faculty has shown us that ties to
industry can affect scientific behavior, leading to such things as trade
secrecy and delays in publishing research. It's possible that similar relationships
with companies could affect IRB members' activities and attitudes.”(18)
Medical Ethics and Conflict of Interest in Scientific Medicine
Jonathan Quick, director of essential drugs and medicines policy
for the World Health Organization (WHO), wrote in a recent WHO
bulletin: "If
clinical trials become a commercial venture in which self-interest
overrules public interest and desire overrules science, then the
social contract which allows research on human subjects in return
for medical advances is broken."(19)
As former editor of the New England Journal of Medicine , Dr. Marcia
Angell struggled to bring greater attention to the problem of commercializing
scientific research. In her outgoing editorial entitled “ Is
Academic Medicine for Sale?” Angell said that growing conflicts
of interest are tainting science and called for stronger restrictions
on pharmaceutical stock ownership and other financial incentives for
researchers:(20) “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 New England Journal in June 2000. In June 2002,
the New England Journal of Medicine announced that it would accept
journalists
who accept money from drug companies because it was too difficult
to find ones who have no ties. Another former editor of the journal,
Dr.
Jerome Kassirer, said that was not the case and that plenty of
researchers are available who do not work for drug companies.(21)
According to
an ABC news report, pharmaceutical companies spend over $2 billion
a year on over 314,000 events attended by doctors.
The ABC news 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 only 50% of the time. It
appears that money can't buy you love but it can buy any "scientific" result
desired.
Cynthia Crossen, a staffer for the Wall Street Journal,
i n 1996 published Tainted Truth : The Manipulation of Fact in
America
, a book about
the widespread practice of lying with statistics.(22) Commenting
on the state of scientific research, she wrote: “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. By l991,
this figure had risen to $2.1 billion.
THE FIRST IATROGENIC STUDY
1. Dr. Lucian L. Leape opened medicine's Pandora's box in
his 1994 paper, “Error in Medicine,” which appeared in the Journal
of the American Medical Association (JAMA).(16) He found that Schimmel
reported in 1964 that 20% of hospital patients suffered iatrogenic
injury, with a 20% fatality rate. In 1981 Steel reported that 36% of
hospitalized patients experienced iatrogenesis with a 25% fatality
rate, and adverse drug reactions were involved in 50% of the injuries.
In 1991, Bedell reported that 64% of acute heart attacks in one hospital
were preventable and were mostly due to adverse drug reactions.
Leape focused on the “Harvard Medical Practice Study” published
in 1991, (16a) which found a 4% iatrogenic injury rate for patients,
with a 14% fatality rate, in 1984 in New York State. From the 98,609
patients injured and the 14% fatality rate, he estimated that in the
entire U.S. 180,000 people die each year partly as a result of iatrogenic
injury.
Why Leape chose to use the much lower figure of 4%
injury for his analysis remains in question. Using
instead the
average of the
rates found in
the three studies he cites (36%, 20%, and 4%) would
have produced
a 20% medical error rate. The number of iatrogenic
deaths using an average
rate of injury and his 14% fatality rate would be
1,189,576.
Leape acknowledged that the literature on medical
errors is sparse and represents only the tip of
the iceberg,
noting that
when
errors are specifically sought out, reported rates
are “distressingly
high.” He cited several autopsy studies with rates as high as
35-40% of missed diagnoses causing death. He also noted that an intensive
care unit reported an average of 1.7 errors per day per patient, and
29% of those errors were potentially serious or fatal.
Leape calculated the error rate in the intensive
care unit study. First, he found that each patient
had an
average
of 178 “activities” (staff/procedure/medical
interactions) a day, of which 1.7 were errors, which means a 1% failure
rate. This may not seem like much, but Leape cited industry standards
showing that in aviation, a 0.1% failure rate would mean two unsafe
plane landings per day at Chicago's O'Hare International Airport; in
the US Postal Service, a 0.1% failure rate would mean 16,000 pieces
of lost mail every hour; and in the banking industry, a 0.1% failure
rate would mean 32,000 bank checks deducted from the wrong bank account.
In trying to determine why there are so many
medical errors, Leape acknowledged the lack
of reporting
of medical errors.
Medical errors
occur in thousands of different locations and
are perceived as isolated and unusual events.
But the
most important
reason that
the problem
of medical errors is unrecognized and growing,
according to Leape, is that doctors and nurses
are unequipped
to deal with
human
error because of the culture of medical training
and practice. Doctors
are taught that mistakes are unacceptable.
Medical mistakes are therefore viewed as a failure of
character and any
error equals
negligence.
No
one is taught what to do when medical errors
do occur. Leape cites McIntyre and Popper,
who said
the “infallibility model” of
medicine leads to intellectual dishonesty with a need to cover up mistakes
rather than admit them. There are no Grand Rounds on medical errors,
no sharing of failures among doctors, and no one to support them emotionally
when their error harms a patient.
Leape hoped his paper would encourage medical
practitioners “to
fundamentally change the way they think about errors and why they occur.” It
has been almost a decade since this groundbreaking work, but the mistakes
continue to soar.
In 1995, a JAMA report noted, "Over a million patients are injured
in US hospitals each year, and approximately 280,000 die annually as
a result of these injuries. Therefore, the iatrogenic death rate dwarfs
the annual automobile accident mortality rate of 45,000 and accounts
for more deaths than all other accidents combined."(23)
At a 1997 press conference, Leape released
a nationwide poll on patient iatrogenesis
conducted by the National
Patient
Safety Foundation
(NPSF), which is sponsored by the American
Medical
Association (AMA).
Leape
is a founding member of NPSF. The survey
found that more than 100 million Americans
have been
affected
directly
or indirectly
by
a medical mistake.
Forty-two percent were affected directly
and 84% personally knew of someone who
had experienced
a medical mistake.(14)
At this press conference, Leape updated
his 1994 statistics, noting that as
of 1997,
medical errors
in inpatient
hospital settings
nationwide could be as high as 3 million
and could cost as much as $200 billion. Leape used a 14% fatality rate to
determine a medical error death rate of 180,000
in 1994.(16) In 1997,
using Leape's
base number
of 3 million errors, the annual death
rate could be as high as 420,000
for hospital inpatients alone.
ONLY A FRACTION OF MEDICAL ERRORS ARE
REPORTED
In 1994, Leape said he was well aware
that medical errors were not being
reported.(16) A study conducted
in two
obstetrical units in
the UK found that only about one-quarter
of adverse incidents were ever
reported, to protect staff, preserve
reputations,
or for fear
of reprisals, including lawsuits.(24).
An analysis by Wald and Shojania
found that
only 1.5% of all adverse events
result in an incident report, and only 6%
of adverse drug
events are
identified properly.
The authors
learned
that the American College of Surgeons
estimates that surgical incident
reports routinely
capture only
5-30% of adverse
events. In one
study, only 20% of surgical complications
resulted in discussion at morbidity
and mortality rounds.(25) From
these studies, it appears that all the
statistics gathered
on medical
errors
may substantially underestimate
the number of adverse drug and
medical therapy
incidents. They
also suggest that our statistics
concerning mortality resulting
from medical
errors may be in fact be conservative
figures.
An article in Psychiatric Times
(April 2000) outlines the stakes
involved
in reporting medical errors.(26)
The authors
found
that the public
is fearful of suffering a fatal
medical error,
and doctors are afraid they will
be sued if they report
an error.
This brings
up the obvious
question: who is reporting medical
errors? Usually it is the patient
or the patient's
surviving
family. If
no one
notices
the error,
it is never reported. Janet Heinrich,
an associate director at the
U.S. General Accounting Office responsible
for health financing and public
health issues,
testified
before a House
subcommittee hearing
on medical
errors that "the full magnitude of their threat to the American
public is unknown” and "gathering valid and useful information
about adverse events is extremely difficult." She acknowledged
that the fear of being blamed, and the potential for legal liability,
played key roles in the underreporting of errors. The Psychiatric Times
noted that the AMA strongly opposes mandatory reporting of medical
errors.(26) If doctors are not reporting, what about nurses? A survey
of nurses found that they also fail to report medical mistakes for
fear of retaliation.(27)
Standard medical pharmacology
texts admit that relatively
few doctors
ever report
adverse drug reactions to
the FDA.(28) The reasons
range from not knowing such
a reporting system exists to fear
of being
sued.(29) Yet the public depends
on this tremendously
flawed system of voluntary
reporting by doctors to know
whether
a drug or a medical intervention
is harmful.
Pharmacology texts also will
tell doctors how hard it
is to separate
drug side
effects from
disease
symptoms. Treatment
failure is
most often attributed to
the disease and not the drug or
doctor. Doctors
are warned, “Probably nowhere else in professional life are mistakes
so easily hidden, even from ourselves.”(30) It may be hard to
accept, but it is not difficult to understand why only 1 in 20 side
effects is reported to either hospital administrators or the FDA.(31,
31a)
If hospitals admitted to
the actual number of errors
for
which they
are responsible,
which is about
20 times what
is reported,
they would
come under intense scrutiny.(32)
Jerry Phillips, associate
director of the
FDA's Office of
Post Marketing Drug
Risk Assessment, confirms
this number. “In the broader area of adverse drug reaction data,
the 250,000 reports received annually probably represent only 5% of
the actual reactions that occur.”(33) Dr. Jay Cohen, who has
extensively researched adverse drug reactions, notes that because only
5% of adverse drug reactions are reported, there are in fact 5 million
medication reactions each year.(34)
A 2003 survey is all the
more distressing because
there seems
to be no improvement
in error reporting,
even
with all the
attention given
to this topic. Dr. Dorothea
Wild surveyed medical
residents at
a community hospital
in Connecticut
and found that
only half
were
aware
that the
hospital had a medical
error-reporting system,
and that the vast
majority did not use
it at all. Dr.
Wild says
this does
not bode
well for the
future. If doctors don't
learn error reporting
in their training,
they
will never use
it. Wild adds
that error
reporting is
the first step
in locating the gaps
in the medical system and
fixing
them. Not even
that first
step has been
taken to
date.(35) PUBLIC
SUGGESTIONS ON IATROGENESIS
In a telephone survey,
1,207 adults ranked
the effectiveness of
the following measures
in reducing preventable
medical errors that
result in serious harm.(36)
(Following each measure
is the percentage of
respondents who ranked
the measure as “very
effective.”)
| |
giving
doctors more time
to spend with patients
(78%)
requiring hospitals to develop systems to avoid medical errors (74%)
better training of health professionals (73%)
using only doctors specially trained in intensive care medicine on intensive
care units (73%)
requiring hospitals to report all serious medical errors to a state agency (71%)
increasing the number of hospital nurses (69%)
reducing the work hours of doctors in training to avoid fatigue (66%)
encouraging hospitals to voluntarily report serious medical errors to a state
agency (62%). |
DRUG IATROGENESIS
Prescription drugs
constitute the major
treatment modality
of scientific medicine.
With the discovery
of the “germ
theory,” medical
scientists convinced
the public that infectious
organisms were the
cause of illness. Finding
the “cure” for
these infections proved
much harder than anyone
imagined. From the
beginning, chemical
drugs promised much
more than they delivered.
But far beyond not
working, the drugs
also caused incalculable
side effects. The drugs
themselves, even when
properly prescribed,
have side effects that
can be fatal, as Lazarou's
study(1) showed. But
human error can make
the situation even
worse.
Medication Errors
A survey of a 1992
national pharmacy database
found a total of 429,827
medication errors from
1,081 hospitals. Medication
errors occurred in
5.22% of patients admitted
to these hospitals
each year. The authors
concluded that at least
90,895 patients annually
were harmed by medication
errors in the US as
a whole.(37)
A 2002 study shows
that 20% of hospital
medications for patients
had dosage errors.
Nearly 40% of these
errors were considered
potentially harmful
to the patient. In
a typical 300-patient
hospital, the number
of errors per day was
40.(38)
Problems involving
patients' medications
were even higher the
following year. The
error rate intercepted
by pharmacists in this
study was 24%, making
the potential minimum
number of patients
harmed by prescription
drugs 417,908.(39)
Recent Adverse Drug
Reactions
More-recent studies
on adverse drug reactions
show that the figures
from 1994 published
in Lazarou's 1998 JAMA
article may be increasing.
A 2003 study followed
400 patients after
discharge from a tertiary
care hospital setting
(requiring highly specialized
skills, technology,
or support services).
Seventy-six patients
(19%) had adverse events.
Adverse drug events
were the most common,
at 66% of all events.
The next most common
event was procedure-related
injuries, at 17%.(40)
In a New England Journal
of Medicine study,
an alarming one in
four patients suffered
observable side effects
from the more than
3.34 billion prescription
drugs filled in 2002.(41)
One of the doctors
who produced the study
was interviewed by
Reuters and commented, "With
these 10-minute appointments,
it's hard for the doctor
to get into whether
the symptoms are bothering
the patients."(42)
William Tierney, who
editorialized on the
New England Journal
study, said “… given
the increasing number
of powerful drugs available
to care for the aging
population, the problem
will only get worse.” The
drugs with the worst
record of side effects
were selective serotonin
reuptake inhibitors
( SSRIs), nonsteroidal
anti-inflammatory drugs
(NSAIDs), and calcium-channel
blockers. Reuters also
reported that prior
research has suggested
that nearly 5% of hospital
admissions (over 1
million per year) are
the result of drug
side effects. But most
of the cases are not
documented as such.
The study found that
one of the reasons
for this failure is
that in nearly two-thirds
of the cases, doctors
could not diagnose
drug side effects or
the side effects persisted
because the doctor
failed to heed the
warning signs.
Medicating Our Feelings
Patients seeking a
more joyful existence
and relief from worry,
stress, and anxiety
often fall victim to
the messages endlessly
displayed on TV and
billboards. Often,
instead of gaining
relief, they fall victim
to the myriad iatrogenic
side effects of antidepressant
medication.
Moreover, a whole generation
of antidepressant users
has been created from
young people growing
up on Ritalin. Medicating
youth and modifying
their emotions must
have some impact on
how they learn to deal
with their feelings.
They learn to equate
coping with drugs rather
than with their inner
resources. As adults,
these medicated youth
reach for alcohol,
drugs, or even street
drugs to cope. According
to JAMA , “Ritalin
acts much like cocaine.”(43)
Today's marketing of
mood-modifying drugs
such as Prozac and
Zoloft ® makes
them not only socially
acceptable but almost
a necessity in today's
stressful world.
Television Diagnosis
To reach the widest
audience possible,
drug companies are
no longer just targeting
medical doctors with
their marketing of
antidepressants. By
1995, drug companies
had tripled the amount
of money allotted to
direct advertising
of prescription drugs
to consumers. The majority
of this money is spent
on seductive television
ads. From 1996 to 2000,
spending rose from
$791 million to nearly
$2.5 billion.(44) This
$2.5 billion represents
only 15% of the total
pharmaceutical advertising
budget. While the drug
companies maintain
that direct-to-consumer
advertising is educational,
Dr. Sidney M. Wolfe
of the Public Citizen
Health Research Group
in Washington, DC,
argues that the public
often is misinformed
about these ads.(45)
People want what they
see on television and
are told to go to their
doctors for a prescription.
Doctors in private
practice either acquiesce
to their patients'
demands for these drugs
or spend valuable time
trying to talk patients
out of unnecessary
drugs. Dr. Wolfe remarks
that one important
study found that people
mistakenly believe
that the “FDA
reviews all ads before
they are released and
allows only the safest
and most effective
drugs to be promoted
directly to the public.”(46)
How Do We Know Drugs
Are Safe?
Another aspect of scientific
medicine that the public
takes for granted is
the testing of new
drugs. Drugs generally
are tested on individuals
who are fairly healthy
and not on other medications
that could interfere
with findings. But
when these new drugs
are declared “safe” and
enter the drug prescription
books, they are naturally
going to be used by
people who are on a
variety of other medications
and have a lot of other
health problems. Then
a new phase of drug
testing called “post-approval” comes
into play, which is
the documentation of
side effects once drugs
hit the market. In
one very telling report,
the federal government's
General Accounting
Office "found
that of the 198 drugs
approved by the FDA
between 1976 and 1985...
102 (or 51.5%) had
serious post-approval
risks... the serious
post-approval risks
(included) heart failure,
myocardial infarction,
anaphylaxis, respiratory
depression and arrest,
seizures, kidney and
liver failure, severe
blood disorders, birth
defects and fetal toxicity,
and blindness."(47)
NBC Television's investigative
show “Dateline” wondered
if your doctor is moonlighting
as a drug company representative.
After a yearlong investigation,
NBC reported that because
doctors can legally
prescribe any drug
to any patient for
any condition, drug
companies heavily promote "off
label" and frequently
inappropriate and untested
uses of these medications,
even though these drugs
are approved only for
the specific indications
for which they have
been tested.(48)
The leading causes
of adverse drug reactions
are antibiotics (17%),
cardiovascular drugs
(17%), chemotherapy
(15%), and analgesics
and anti-inflammatory
agents (15%).(49)
Specific Drug Iatrogenesis:
Antibiotics
According to William
Agger, MD, director
of microbiology and
chief of infectious
disease at Gundersen
Lutheran Medical Center
in La Crosse, WI, 30
million pounds of antibiotics
are used in America
each year.(50) Of this
amount, 25 million
pounds are used in
animal husbandry, and
23 million pounds are
used to try to prevent
disease and the stress
of shipping, as well
as to promote growth.
Only 2 million pounds
are given for specific
animal infections.
Dr. Agger reminds us
that low concentrations
of antibiotics are
measurable in many of our foods and in
various waterways around
the world, much of
it seeping in from
animal farms.
Agger contends that
overuse of antibiotics
results in food-borne
infections resistant
to antibiotics. Salmonella
is found in 20% of
ground meat, but the
constant exposure of
cattle to antibiotics
has made 84% of salmonella
resistant to at least
one anti-salmonella
antibiotic. Diseased
animal food accounts
for 80% of salmonellosis
in humans, or 1.4 million
cases per year. The
conventional approach
to countering this
epidemic is to radiate
food to try to kill
all organisms while
continuing to use the
antibiotics that created
the problem in the first place. Approximately
20% of chickens are
contaminated with Campylobacter
jejuni, an organism
that causes 2.4 million
cases of illness annually.
Fifty-four percent
of these organisms
are resistant to at
least one anti-campylobacter
antimicrobial agent.
Denmark banned growth-promoting
antibiotics beginning
in 1999, which cut
their use by more than
half within a year,
from 453,200 to 195,800
pounds. A report from
Scandinavia found that
removing antibiotic
growth promoters had
no or minimal effect
on food production
costs. Agger warns
that the current crowded,
unsanitary methods
of animal farming in
the US support constant
stress and infection,
and are geared toward
high antibiotic use.
In the US, over 3 million
pounds of antibiotics
are used every year
on humans. With a population
of 284 million Americans,
this amount is enough
to give every man,
woman, and child 10
teaspoons of pure antibiotics
per year. Agger says
that exposure to a
steady stream of antibiotics
has altered pathogens
such as Streptococcus
pneumoniae, Staplococcus
aureus, and entercocci,
to name a few.
Almost half of patients
with upper respiratory
tract infections in
the U.S. still receive
antibiotics from their
doctor.(51) According
to the CDC, 90% of
upper respiratory infections
are viral and should
not be treated with
antibiotics. In Germany,
the prevalence of systemic
antibiotic use in children
aged 0-6 years was
42.9%.(52)
Data obtained from
nine US health insurers
on antibiotic use in
25,000 children from
1996 to 2000 found
that rates of antibiotic
use decreased. Antibiotic
use in children aged
three months to under
3 years decreased 24%,
from 2.46 to 1.89 antibiotic
prescriptions per patient
per year. For children
aged 3 to under 6 years,
there was a 25% reduction
from 1.47 to 1.09 antibiotic
prescriptions per patient
per year. And for children
aged 6 to under 18
years, there was a
16% reduction from
0.85 to 0.69 antibiotic
prescriptions per patient
per year.(53) Despite
these reductions, the data indicate that
on average every child
in America receives
1.22 antibiotic prescriptions
annually.
Group A beta-hemolytic
streptococci is the
only common cause of
sore throat that requires
antibiotics, with penicillin
and erythromycin the
only recommended treatment.
Ninety percent of sore-throat
cases, however, are
viral. Antibiotics
were used in 73% of
the estimated 6.7 million
adult annual visits
for sore throat in
the US between 1989
and 1999. Furthermore,
patients treated with
antibiotics were prescribed
non-recommended broad-spectrum
antibiotics in 68%
of visits. This period
saw a significant increase
in the use of newer,
more expensive broad-spectrum
antibiotics and a decrease in use of the recommended
antibiotics penicillin
and erythromycin.(54)
A ntibiotics being
prescribed in 73% of
sore-throat cases instead
of the recommended
10% resulted in a total
of 4.2 million unnecessary
antibiotic prescriptions
from 1989 to 1999.
The Problem with Antibiotics
In September 2003,
the CDC re-launched
a program started in
1995 called “Get
Smart: Know When Antibiotics
Work.”(55) This
$1.6 million campaign
is designed to educate
patients about the
overuse and inappropriate
use of antibiotics.
Most people involved
with alternative medicine
have known about the
dangers of antibiotic
overuse for decades.
Finally the government
is focusing on the
problem, yet it is
spending only a miniscule
amount of money on
an iatrogenic epidemic
that is costing billions
of dollars and thousands
of lives. The CDC warns
that 90% of upper respiratory
infections, including
children's ear infections,
are viral and that
antibiotics do not
treat viral infection.
More than 40% of about
50 million prescriptions
for antibiotics written
each year in physicians'
offices are inappropriate.(2)
U sing antibiotics
when not needed can
lead to the development
of deadly strains of
bacteria that are resistant
to drugs and cause
more than 88,000 deaths
due to hospital-acquired
infections.(9) The
CDC, however, seems
to be blaming patients
for misusing antibiotics
even though they are
available only by prescription
from physicians. According
to Dr. Richard Besser,
head of “Get
Smart”: "Programs
that have just targeted
physicians have not
worked. Direct-to-consumer
advertising of drugs
is to blame in some
cases.” Besser
says the program “teaches
patients and the general
public that antibiotics
are precious resources
that must be used correctly
if we want to have
them around when we
need them. Hopefully,
as a result of this
campaign, patients
will feel more comfortable
asking their doctors
for the best care for
their illnesses, rather
than asking for antibiotics."(56
What constitutes the “best
care”? The CDC
does not elaborate
and ignores the latest
research on the dozens
of nutraceuticals that
have been scientifically
proven to treat viral
infections and boost
immune-system function.
Will doctors recommend
vitamin C, echinacea,
elderberry, vitamin
A, zinc, or homeopathic
oscillococcinum? Probably
not. The CDC's common-sense
recommendations that
most people follow
anyway include getting
proper rest, drinking
plenty of fluids, and
using a humidifier.
1. The pharmaceutical
industry claims it
supports limiting the
use of antibiotics.
The drug company Bayer
sponsors a program
called “Operation
Clean Hands” through
an organization called
LIBRA.(57) The CDC
also is involved in
trying to minimize
antibiotic resistance,
but nowhere in its
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
tunnel vision and refusal
to recommend the available
non-drug alternatives
is unfortunate when
the CDC is desperately
trying to curb the
overuse of antibiotics.
Drugs Pollute Our Water
Supply
We have reached the
point of saturation
with prescription drugs.
Every body of water
tested contains measurable
drug residues. 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 also
are 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
way to know the long-term
health consequences
of ingesting a mixture of drugs and drug-breakdown
products. These drugs
represent another level
of iatrogenic disease
that we are unable
to completely measure.(58-67)
Specific Drug Iatrogenesis:
NSAIDs
It's not just the US
that is plagued by
iatrogenesis. A survey
of more than 1,000
French general practitioners
(GPs) tested their
basic pharmacological
knowledge and practice
in prescribing NSAIDs,
which rank first among
commonly prescribed
drugs for serious adverse
reactions. The study
results suggest that
GPs do not have adequate
knowledge of these
drugs and are unable
to effectively manage
adverse reactions.(68)
A cross-sectional survey
of 125 patients attending
specialty pain clinics
in South London found
that possible iatrogenic
factors such as “over-investigation,
inappropriate information,
and advice given to
patients as well as
misdiagnosis, over-treatment,
and inappropriate prescription
of medication were
common.”(69)
Specific Drug Iatrogenesis:
Cancer Chemotherapy
In 1989, German biostatistician
Ulrich Abel, PhD, wrote
a monograph entitled “Chemotherapy
of Advanced Epithelial
Cancer.” It was
later published in
shorter form in a peer-reviewed
medical journal.(70)
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
with which we are most
familiar, arising from
epithelium found in
the lining of body
organs such as the
breast, prostate, lung,
stomach, and bowel.
From these sites, cancer
usually infiltrates
adjacent tissue and
spreads to the bone,
liver, lung, or brain.
With his exhaustive
review, Abel concluded
there is no direct
evidence that chemotherapy
prolongs survival in
patients with advanced
carcinoma; in small-cell
lung cancer and perhaps
ovarian cancer, the
therapeutic benefit
is only slight. According
to Abel, “Many
oncologists take it
for granted that response
to therapy prolongs
survival, an opinion
which is based on a
fallacy and which is
not supported by clinical
studies.”
Over a decade after
Abel's exhaustive review
of chemotherapy, there
seems no decrease in
its use for advanced
carcinoma. For example,
when conventional chemotherapy
and radiation have
not worked to prevent
metastases in breast
cancer, high-dose chemotherapy
(HDC) along with stem-cell
transplant (SCT) is
the treatment of choice.
In March 2000, however,
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) with even a slightly
lower survival rate
for the HDC/SCT group.
Serious adverse effects
occurred more often
in the HDC group than
the standard-dose group.
One treatment-related
death (within 100 days
of therapy) was recorded
in the HDC group, but
none was recorded in
the conventional chemotherapy
group. The women in
this trial were highly
selected as having
the best chance to
respond.
Unfortunately, no all-encompassing
follow-up study such
as Dr. Abel's exists
to indicate whether
there has been any
improvement in cancer-survival
statistics since 1989.
In fact, research should
be conducted to determine
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 are not
used.
Drug Companies Fined
Periodically, the FDA
fines a drug manufacturer
when its abuses are
too glaring and impossible
to cover up. In May
2002, The Washington
Post reported that
Schering-Plough Corp.,
the maker of Claritin,
was to pay a $500 million
dollar fine to the
FDA for quality-control
problems at four of
its factories.(72)
The indictment came
after the Public Citizen
Health Research Group,
led 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.
The FDA tabulated infractions
involving 125 products,
or 90% of the drugs
made by Schering-Plough
since 1998. Besides
paying the fine, the
company was forced
to halt the manufacture
of 73 drugs or suffer
another $175 million
fine. Schering-Plough's
news releases told
another story, assuring
consumers that they
should still feel confident
in the company's products.
This large settlement
served 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
has paid a $100 million
fine for failing to
meet quality standards
in the production of
medical test kits,
while Wyeth Laboratories
paid $30 million in
2000 to settle accusations
of poor manufacturing
practices.
UNNECESSARY SURGICAL
PROCEDURES
In 1974, 2.4 million
unnecessary surgeries
were performed, resulting
in 11,900 deaths at
a cost of $3.9 billion.(73,74)
In 2001, 7.5 million
unnecessary surgical
procedures were performed,
resulting in 37,136
deaths at a cost of
$122 billion (using
1974 dollars).(3)
It is very difficult
to obtain accurate
statistics when studying
unnecessary surgery.
In 1989, Leape wrote
that perhaps 30% of
controversial surgeries—which
include cesarean section,
tonsillectomy, appendectomy,
hysterectomy, gastrectomy
for obesity, breast
implants, and elective
breast implants(74)— are
unnecessary. In 1974,
the Congressional Committee
on Interstate and Foreign
Commerce held hearings
on unnecessary surgery.
It 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)
According to the
Healthcare Cost
and Utilization
Project within the
Agency for Healthcare
Research and Quality(13),
in 2001 the 50 most
common medical and
surgical procedures
were performed approximately
41.8 million times
in the US. Using
the
1974 House Subcommittee
on Oversight and
Investigations'
figure of 17.6% as
the percentage of
unnecessary surgical
procedures,
and extrapolating
from the death
rate in 1974,
produces nearly 7.5
million (7,489,718)
unnecessary procedures
and a death rate
of 37,136, at a
cost of
$122 billion (using
1974 dollars).
In 1995, researchers
conducted a similar
analysis of back surgery
procedures, using the
1974 “unnecessary
surgery percentage” of
17.6. Testifying before
the Department of Veterans
Affairs, they estimated
that of the 250,000
back surgeries performed
annually in the US
at a hospital cost
of $11,000 per patient,
the total number of
unnecessary back surgeries
approaches 44,000,
costing as much as
$484 million.(75)
Like prescription drug
use driven by television
advertising, unnecessary
surgeries are escalating.
Media-driven surgery
such as gastric bypass
for obesity “modeled” by
Hollywood celebrities
seduces obese people
to think this route
is safe and sexy. Unnecessary
surgeries have even
been marketed on the
Internet.(76) A study
in Spain declares that
20-25% of total surgical
practice represents
unnecessary operations.(77)
According to data from
the National Center
for Health Statistics
for 1979 to 1984, the
total number of surgical
procedures increased
9% while the number
of surgeons grew 20%.
The study notes that
the large increase
in the number of surgeons
was not accompanied
by a parallel increase
in the number of surgeries
performed, and expressed
concern about an excess
of surgeons to handle
the surgical caseload.(78)
From 1983 to 1994,
however, the incidence
of the 10 most commonly
performed surgical
procedures jumped 38%,
to 7,929,000 from 5,731,000
cases. By 1994, cataract
surgery was the most
common procedure with
more than 2 million
operations, followed
by cesarean section
(858,000 procedures)
and inguinal hernia
operations (689,000
procedures). Knee arthroscopy
procedures increased
153% while prostate
surgery declined 29%.(79)
The list of iatrogenic
complications from
surgery is as long
as the list of procedures
themselves. One study
examined catheters
that were inserted
to deliver anesthetic
into the epidural space
around the spinal nerves
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
found “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 coronary
angiography procedures,
32% of carotid endarterectomy
procedures, and 17%
of upper gastrointestinal
tract endoscopy procedures.(82)
Based on the Healthcare
Cost and Utilization
Project (HCUP) statistics
provided by the government
for 2001, 697,675 upper
gastrointestinal endoscopies
(usually entailing
biopsy) were performed,
as were 142,401 endarterectomies
and 719,949 coronary
angiographies.(13)
Extrapolating the JAMA
study's inappropriate
surgery rates to 2001
produces 118,604 unnecessary
endoscopy procedures,
45,568 unnecessary
endarterectomies, and
122,391 unnecessary
coronary angiographies.
These are all forms
of medical iatrogenesis.
MEDICAL AND SURGICAL
PROCEDURES
It is instructive to
know the mortality
rates associated with
various medical and
surgical procedures.
Although we must sign
release forms when
we undergo any procedure,
many of us are in denial
about the true risks
involved; because medical
and surgical procedures
are so commonplace,
they often are seen
as both necessary and
safe. Unfortunately,
allopathic medicine
itself is a leading
cause of death, as
well as the most expensive
way to die.
Perhaps the words “health
care” confer
the illusion that medicine
is about health. Allopathic
medicine is not a purveyor
of health care but
of disease care. The
HCUP figures are instructive,(13)
but the computer program
that calculates annual
mortality statistics
for all US hospital
discharges is only
as good as the codes
entered into the system.
In email correspondence,
HCUP indicated that
the mortality rates
for each procedure
indicated only that
someone undergoing
that procedure died
either from the procedure
or from some other
cause.
Thus there is no way
of knowing exactly
how many people die
from a particular procedure.
While codes for “poisoning & toxic
effects of drugs” and “complications
of treatment” do
exist, the mortality
figures registered
in these categories
are very low and do
not correlate with
what is known from
research such as the
1998 JAMA study(1)
that estimated an average
of 106,000 prescription
medication deaths per
year. No codes exist
for adverse drug side
effects, surgical mishaps,
or other types of medical
error. Until such codes
exist, the true mortality
rates tied to of medical
error will remain buried
in the general statistics.
AN HONEST LOOK AT US
HEALTH CARE
In 1978, the US Office
of Technology Assessment
(OTA) reported: “Only
10-20% of all procedures
currently used in medical
practice have been
shown to be efficacious
by controlled trial."(83)
In 1995, the OTA compared
medical technology
in eight countries
( Australia , Canada,
France, Germany, the
Netherlands, Sweden,
the UK, and the US
) and again noted that
few medical procedures
in the US have been
subjected to clinical
trial. It also reported
that US infant mortality
was high and life expectancy
low compared to other
developed countries.(84)
Although almost 10
years old, much of
what was written in
the OTA report holds
true today. The report
blames the high cost
of American medicine
on the medical free-enterprise
system and failure
to create a national
health care policy.
It attributes the government's
failure to control
health care costs to
market incentives and
profit motives inherent
in the current financing
and organization of
health care, which
includes such interests
as private health insurers,
hospital systems, physicians,
and the drug and medical-device
industries. “Health
Care Technology and
Its Assessment in Eight
Countries” is
the last report prepared
by the OTA, which was
disbanded in 1995.
It also is perhaps
the US government's
last honest, detailed
examination of the
nation's health care
system. An appendix
summarizing this 60-page
report follows this
article.
SURGICAL ERRORS FINALLY
REPORTED
An October 2003 JAMA
study from the US 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 hospital
days in 2000.(85) Data
from 20% of the nation's
hospitals were analyzed
for 18 different surgical
complications, including
postoperative infections,
foreign objects left
in wounds, surgical
wounds reopening, and
post-operative bleeding.
In a press release
accompanying the study,
AHRQ director Carolyn
M. Clancy, MD, noted: “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)
According to the study's
authors, “The
findings greatly underestimate
the problem, since
many other complications
happen that are not
listed in hospital
administrative data.” They
added: "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." The
study authors said
that improved medical
practices, including
an emphasis on better
hand washing, might
help reduce morbidity
and mortality rates.
In an accompanying
JAMA editorial, health-risk
researcher Dr. Saul
Weingart of Harvard's
Beth Israel-Deaconess
Medical Center wrote, “Given
their staggering magnitude,
these estimates are
clearly sobering.”(87)
UNNECESSARY X-RAYS
When x-rays were discovered,
no one knew the long-term
effects of ionizing
radiation. In the 1950s,
monthly fluoroscopic
exams at the doctor's
office were routine,
and you could even
walk into most shoe
stores and see x-rays
of your foot bones.
We still do not know
the ultimate outcome
of our initial fascination
with x-rays.
In those days, it was
common practice to
x-ray pregnant women
to measure their pelvises
and make a diagnosis
of twins. Finally,
a study of 700,000
children born between
1947 and 1964 in 37
major maternity hospitals
compared the children
of mothers who had
received pelvic x-rays
during pregnancy to
those of mothers who
did not. It found that
cancer mortality was
40% higher among children
whose mothers had been
x-rayed.(88)
In present-day medicine,
coronary angiography
is an invasive surgical
procedure that involves
snaking a tube through
a blood vessel in the
groin up to the heart.
To obtain useful information,
X-rays are taken almost
continuously, with
minimum dosages ranging
from 460 to 1,580 mrem.
The minimum radiation
from a routine chest
x-ray is 2 mrem. X-ray
radiation accumulates
in the body, and ionizing
radiation used in X-ray
procedures has been
shown to cause gene
mutation. The health
impact of this high
level of radiation
is unknown, and often
obscured 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 mrem.”(89)
Dr. John Gofman has
studied the effects
of radiation on human
health for 45 years.
A medical doctor with
a PhD in nuclear and
physical chemistry,
Gofman worked on the
Manhattan Project,
discovered uranium-233,
and was the first person
to isolate plutonium.
In five scientifically
documented books, Gofman
provides strong evidence
that medical technology—specifically
x-rays, CT scans, and
mammography and fluoroscopy
devices—are a
contributing factor
to 75% of new cancers.
In a nearly 700-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)
Gofman shows that as
the number of physicians
increases in a geographical
area along with an
increase in the number
of x-ray diagnostic
tests performed, the
rate of cancer and
ischemic heart disease
also increases. Gofman
elaborates that it
is not x-rays alone
that cause the damage
but a combination of
health risk factors
that include poor diet,
smoking, abortions,
and the use of birth
control pills. Dr.
Gofman predicts that
ionizing radiation
will be responsible
for 100 million premature
deaths over the next
decade.
In his book, “Preventing
Breast Cancer,” Dr.
Gofman notes that breast
cancer is the leading
cause of death among
American women between
the ages of 44 and
55. Because breast
tissue is highly sensitive
to radiation, mammograms
can cause cancer. The
danger can be heightened
other factors including
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. John E. Sarno,
a well-known New York
orthopedic surgeon,
found that there is
not necessarily any
association between
back pain and spinal
x-ray abnormality.
He cites studies of
normal people without
a trace of back pain
whose x-rays indicate
spinal abnormalities
and of people with
back pain whose spines
appear to be normal
on x-ray.(92) People
who happen to have
back pain and show
an abnormality on x-ray
may be treated surgically,
sometimes with no change
in back pain, worsening
of back pain, or even
permanent disability.
Moreover, doctors often
order x-rays as protection
against malpractice
claims, to give the
impression of leaving
no stone unturned.
It appears that doctors
are putting their own
fears before the interests
of their patients.
UNNECESSARY HOSPITALIZATION
Nearly 9 million (8,925,033)
people were hospitalized
unnecessarily in
2001.(4) In a study
of inappropriate
hospitalization,
two doctors reviewed
1,132 medical records.
They concluded that
23% of all admissions
were inappropriate
and an additional
17% could have been
handled in outpatient
clinics. Thirty-four
percent of all hospital
days were deemed
inappropriate and
could have been avoided.(93)
The rate of inappropriate
hospital admissions
in 1990 was 23.5%.(94)
In 1999, another
study also found
an inappropriate admissions rate of
24%, indicating a
consistent pattern
from 1986 to 1999.(95)
The HCUP database
indicates that the
total number of patient
discharges from US
hospitals in 2001
was 37,187,641,(13)
meaning that almost
9 million people
were exposed to unnecessary
medical intervention
in hospitals and
therefore represent
almost 9 million
potential iatrogenic
episodes.(4)
WOMEN'S EXPERIENCE
IN MEDICINE
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 10 hysterical
women each day, transforming
them into “iatrogenic
monsters” and
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. According to
Dr. Adriane Fugh-Berman,
US medicine has a tradition
of excessive medical
and surgical interventions
on women. Only 100
years ago, male doctors
believed 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.
Fugh-Berman notes that
US doctors eventually
disabused themselves
of that notion but
have continued to treat
women very differently
than they treat men.(97)
She cites the following
statistics:
- Thousands
of prophylactic
mastectomies are
performed annually.
- One-third of US
women have
had a hysterectomy
before menopause.
Women are prescribed
drugs more
frequently
than are men.
- Women are given
potent drugs
for disease prevention,
which results
in disease
substitution
due to side
effects.
- Fetal monitoring
is unsupported
by studies
and not recommended
by the CDC.(98)
It
confines women
to a hospital
bed
and may
result in a
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,
but does
increase the risk
of breast
cancer,
heart disease,
stroke, and
gall bladder attack.(100)
As
many as one-third of
postmenopausal women
use HRT.(101,102) This
number is important
in light of the much-publicized
Women's Health Initiative
Study, which was halted
before its completion
because of a higher
death rate in the synthetic
estrogen-progestin
(HRT) group.(103
Cesarean Section
1. In 1983, 809,000
cesarean sections (21%
of live births) were
performed in the US,
making it the nation's
most common obstetric-gynecologic
(OB/GYN) surgical procedure.
The second most common
OB/GYN operation was
hysterectomy (673,000),
followed by diagnostic
dilation and curettage
of the uterus (632,000).
In 1983, OB/GYN procedures
represented 23% of
all surgery completed
in the US.(104)
In 2001, cesarean section
is still the most common
OB/GYN surgical procedure.
Approximately 4 million
births occur annually,
with 24% (960,000)
delivered by cesarean
section. In the Netherlands,
only 8% of births are
delivered by cesarean
section. This suggests
640,000 unnecessary
cesarean sections—entailing
three to four times
higher mortality and
20 times greater morbidity
than vaginal delivery(105)—are
performed annually
in the US.
The US cesarean rate
rose from just 4.5%
in 1965 to 24.1% in
1986. Sakala contends
that 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.(107)
NEVER ENOUGH STUDIES
Scientists claimed
there were never enough
studies revealing the
dangers of DDT and
other dangerous pesticides
to ban them. They also
used this argument
for 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 the
results of tobacco
research. In 1964,
when the Surgeon General's
report condemned smoking,
the AMA refused to
endorse it, claiming
a need for more research.
What they really wanted
was more money, which
they received from
a consortium of tobacco
companies that paid
the AMA $18 million
over the next nine
years during which
the AMA said nothing
about the dangers of
smoking.(108)
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 advertisements
for Chesterfield cigarettes
that claimed 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
more studies are needed
before they will support
restricting the inordinate
use of drugs.
ADVERSE DRUG REACTIONS
The Lazarou study(1)
analyzed records for
prescribed medications
for 33 million US hospital
admissions in 1994.
It discovered 2.2 million
serious injuries due
to prescribed drugs;
2.1% of inpatients
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 inpatients
and 0.13% of admissions.
The authors estimated
that 106,000 deaths
occur annually due
to adverse drug reactions.
Using a cost analysis
from a 2000 study in
which the increase
in hospitalization
costs per patient suffering
an adverse drug reaction
was $5,483, 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 FDA approval
of the drugs involved.
The safety of new agents
cannot be known with
certainty until a drug
has been on the market
for many years.(110)
BEDSORES
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, cited
20% of the nation's
17,000 nursing homes
for violations between
July 2000 and January
2002. Many violations
involved serious physical
injury and death.(111)
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 are not able to
manage a food tray
by themselves.(11)
It is difficult to
place a mortality rate
on malnutrition and
dehydration. The Coalition
report states that
malnourished residents,
compared with well-nourished
hospitalized nursing
home residents, have
a fivefold increase
in mortality when they
are admitted to a hospital.
Multiplying the one-third
of 1.6 million nursing
home residents who
are malnourished by
a mortality rate of
20%(8,14) results in
108,800 premature deaths
due to malnutrition
in nursing homes.
Nosocomial Infections
The rate of nosocomial
infections per 1,000
patient days rose from
7.2 in 1975 to 9.8
in 1995, a 36% jump
in 20 years. Reports
from more than 270
US 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,
a rate of 5-6%. Due
to progressively shorter
inpatient stays and
the increasing number
of admissions, however,
the number of infections
increased. It is estimated
that in 1995, nosocomial
infections cost $4.5
billion and contributed
to more than 88,000
deaths, or one death
every 6 minutes.(9)
The 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) representing
a $0.5 billion increase
in just four years.
At this rate of increase,
the current cost of
nosocomial infections
would be around $5.5
billion.
Outpatient Iatrogenesis
In a 2000 JAMA article,
Dr. Barbara Starfield
presents well-documented
facts that are both
shocking and unassailable.(12)
The U.S. ranks 12th
of 13 industrialized
countries when judged
by 16 health status
indicators. Japan,
Sweden, and Canada
were first, second,
and third, respectively.
More than 40 million
people in the US have
no health insurance,
and 20-30% of patients
receive contraindicated
care.
Starfield warns that
one cause of medical
mistakes is overuse
of technology, which
may create a "cascade
effect" leading
to still more treatment.
She urges the use of
ICD (International
Classification of Diseases)
codes that have designations
such as "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
notes that many deaths
attributable to medical
error today are likely
to be coded to indicate
some other cause of
death. She concludes
that against the backdrop
of our poor health
report card compared
to other Westernized
countries, we should
recognize that the
harmful effects of
health care interventions
account for a substantial
proportion of our excess
deaths. Starfield cites Weingart's
2000 article, “Epidemiology
of Medical Error,” as
well as other authors
to suggest that between
4% and 18% of consecutive
patients in outpatient
settings suffer an
iatrogenic event leading
to:
- 116
million extra
physician visits
- 77 million extra
prescriptions filled
- 17 million emergency
department
visits
- 8 million hospitalizations
- 3 million long-term
admissions
- 199,000 additional
deaths
- $77 billion
in
extra costs(112)
Unnecessary Surgeries
While some 12,000
deaths occur each
year from
unnecessary surgeries,
results from the few
studies that have measured
unnecessary surgery
directly indicate that
for some highly controversial
operations, the proportion
of unwarranted surgeries
could be as high as
30%.(74)
MEDICAL ERRORS: A
GLOBAL ISSUE
A five-country survey
published in the Journal
of Health Affairs found
that 18-28% 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.
The breakdown by country
showed the percentages
of those suffering
a medical or drug error
were 18% in Britain,
23% in Australia and
in New Zealand, 25%
in Canada, and 28%
in the US.(113)
HEALTH INSURANCE
The Institute of
Medicine recently
found that
the 41 million Americans
with no health insurance
have consistently worse
clinical outcomes than
those who are insured,
and are at increased
risk for dying prematurely
(114).
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
US GAO estimated that
$12 billion dollars
was lost to fraudulent
or unnecessary claims
in 1998, 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 health
care fraud cases and
proceedings.(115)
WAREHOUSING OUR ELDERS
One way to measure
the moral and ethical
fiber of a society
is by how it treats
its weakest and most
vulnerable members.
In some cultures, elderly
people lives out their
lives in extended family
settings that enable
them to continue participating
in family and community
affairs. American nursing
homes, where millions
of our elders go to
live out their final
days, represent the
pinnacle of social
isolation and medical
abuse.
| |
In
America, approximately
1.6 million
elderly are
confined to
nursing homes.
By 2050, that
number could
be 6.6 million.(11,116)
Twenty percent
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) |
Presenting
a report he sponsored
entitled "Abuse
of Residents is a Major
Problem in U.S. Nursing
Homes" on July
30, 2001, Rep. Henry
Waxman (D-CA) noted
that “as a society
we will be judged by
how we treat the elderly." The
report found one-third
of the nation's approximately
17,000 nursing homes
were cited for an abuse
violation in a two-year
period from January
1999 to January 2001.(116)
According to Waxman, “the
people who cared for
us deserve better." The
report suggests that
this known abuse represents
only the “tip
of the iceberg” and
that much more abuse
occurs that we aware
of or ignore.(116a)
The report found:
| |
Over
30% of US nursing
homes were cited
for abuses, totaling
more than 9,000
violations.
10% of nursing homes had violations that caused actual physical harm to residents
or worse.
Over 40% (3,800) of the abuse violations followed the filing of a formal complaint,
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 injuries. |
Dangerously understaffed
nursing homes lead
to neglect, abuse,
overuse of medications,
and physical restraints.
In 1990, Congress mandated
an exhaustive study
of nurse-to-patient
ratios in nursing homes.
The study was finally
begun in 1998 and took
four years to complete.(120)
A spokesperson for
The National Citizens'
Coalition for Nursing
Home Reform commented
on the study: “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 as ‘insufficient.'”(121)
Although preventable
with proper nursing
care, bedsores occur
three times more commonly
in nursing homes than
in acute care or veterans
hospitals.(122).
Because many nursing
home patients suffer
from chronic debilitating
conditions, their
assumed cause
of death often
is 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
possible that many
nursing home deaths
are instead attributed
to heart disease.
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 8-24%. In the
elderly,
the overreporting
of heart disease
as a
cause of death is
as much as twofold.(125) That very few statistics
exist concerning malnutrition
in acute-care hospitals
and nursing homes demonstrates
the lack of concern
in this area. While
a survey of the literature
turns up few US studies,
one revealing US study
evaluated the nutritional
status of 837 patients
in a 100-bed subacute-care
hospital over a 14-month
period. The study found
only 8% of the patients
were well nourished,
while 29% were malnourished
and 63% were at risk
of malnutrition. As
a result, 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 subacute-care
facility.(126)
Many studies conclude
that physical restraints
are an underreported
and preventable cause
of death. Studies show
that compared to no
restraints, the use
of restraints carries
a higher mortality
rate and economic burden.(127-129)
Studies have found
that physical restraints,
including bedrails,
are the cause of at
least 1 in every 1,000
nursing-home deaths.(130-132)
Deaths caused by malnutrition,
dehydration, and physical
restraints, however,
are rarely recorded
on death certificates.
Several studies reveal
that nearly half of
the listed causes of
death on death certificates
for elderly people
with chronic or multi-system
disease are inaccurate.(133)
Even though 1 in 5
people die in nursing
homes, an autopsy is
performed in less than
1% of these deaths.(134).
Overmedicating Seniors
Dr. Robert Epstein,
chief medical officer
of Medco Health Solutions
Inc. (a unit of Merck & Co.),
conducted a study in
2003 of drug trends
among the elderly.(135)
He found that seniors
are going to multiple
physicians, getting
multiple prescriptions,
and using multiple
pharmacies. Medco oversees
drug-benefit plans
for more than 60 million
Americans, including
6.3 million seniors
who received more than
160 million prescriptions.
According to the study,
the average senior
receives 25 prescriptions
each year. Among 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 seniors, 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 noted: “There
are serious and systemic
problems with poor
continuity of care
in the United States.” He says this
study represents only “the
tip of the iceberg” of
a national problem.
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 total number of
prescriptions written
in the US in 2000 was
2.98 billion, or 10.4
prescriptions for every
man, woman, and child.(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 their use.(138)
Seniors
and groups like the
American Association
for Retired Persons
(AARP) are demanding
that prescription drug
coverage be a basic
right.(139) They have
accepted allopathic
medicine's overriding
assumption that aging
and dying in America
must be accompanied
by drugs in nursing
homes and eventual
hospitalization. Seniors
are given the choice
of either high-cost
patented drugs or low-cost
generic drugs. Drug
companies attempt to
keep the most expensive
drugs on the shelves
and suppress access
to generic drugs, despite
facing stiff fines
of hundreds of millions
of dollars levied by
the federal government.(140,141)
In 2001, some of the
world's largest drug
companies were fined
a record $871 million
for conspiring to increase
the price of vitamins.(142)
Current AARP recommendations
for diet and nutrition
assume that seniors
are getting all the
nutrition they need
in an average diet.
At most, AARP suggests
adding extra calcium
and a multivitamin
and mineral supplement.(143)
Ironically, studies
also indicate underuse
of proper pain medication
for patients who need
it. One study evaluated
pain management in
a group of 13,625 cancer
patients, aged 65 and
over, living in nursing
homes. While almost
30% of the patients
reported pain, more
than 25% received no
pain relief medication,
16% received a mild
analgesic drug, 32%
received a moderate
analgesic drug, and
26% received adequate
pain-relieving morphine.
The authors concluded
that older patients
and minority patients
were more likely to
have their pain untreated.(144)
WHAT REMAINS TO BE
UNCOVERED
Our ongoing research
will continue to
quantify the morbidity,
mortality,
and financial loss
due to:
| |
X-ray
exposures (mammography,
fluoroscopy, CT
scans).
1. Overuse of antibiotics for all conditions.
2. Carcinogenic drugs (hormone replacement therapy,* immunosuppressive and prescription
drugs).
3. Cancer chemotherapy(70)
4. Surgery and unnecessary surgery (cesarean section, radical mastectomy, preventive
mastectomy, radical hysterectomy, prostatectomy, cholecystectomies, cosmetic
surgery, arthroscopy, etc.).
5. Discredited medical procedures and therapies.
6. Unproven medical therapies.
7. Outpatient surgery.
8. Doctors themselves. |
*
Part of our ongoing
research will be
to quantify the
mortality
and morbidity caused
by hormone replacement
therapy (HRT) since
the 1940s. 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 US.(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,
with little evidence
of osteoporosis reduction
or dementia prevention.
WHI researchers,
who usually never
make
recommendations except
to suggest more studies,
advised doctors to
be very cautious
about prescribing
HRT to
their patients.(100,146-150)
Results of the “Million
Women Study” on
HRT and breast cancer
in the UK were published
in medical journal
The Lancet in August
2003. According to
lead author Prof. Valerie
Beral, director of
the Cancer Research
UK Epidemiology Unit: "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, estrogen-progestagen
(combination) therapy
accounting for 15,000
of these.”(151)
We were unable to find
statistics on breast
cancer, stroke, uterine
cancer, or heart disease
caused by HRT used
by American women.
Because the US population
is roughly six times
that of the UK, it
is possible that 120,000
cases of breast cancer
have been caused by
HRT in the past decade.
| |
1. OFFICE OF TECHNOLOGY ASSESSMENT (OTA)
Health Care Technology and Its Assessment in Eight Countries, 1995.
General Facts
1. In 1990, US life expectancy was 71.8 years for men and 78.8 years for women,
among the lowest rates in the developed countries.
2. The 1990 US infant mortality rate in the US was 9.2 per 1,000 live births,
in the bottom half of the distribution among all developed countries.
3. Health status is correlated with socioeconomic status.
4. Health care is not universal.
5. Health care is based on the free market system with no fixed budget or limitations
on expansion.
6. Health care accounts for 14% of the US GNP ($800 billion in 1993).
7. The federal government does no central planning, though it is the major purchaser
of health care for older people and some poor people.
8. Americans are less satisfied with their health care system than people in
other developed countries.
9. US medicine specializes in expensive medical technology; some large US cities
have more magnetic resonance image (MRI) scanners than most countries.
10. Huge public and private investments in medical research and pharmaceutical
development drive this “technological arms race.”
11. Any efforts to restrain technological developments in health care are opposed
by policymakers concerned about negative impacts on medical-technology industries. |
Hospitals
| |
1. In 1990, the US had 5,480 acute-care hospitals,
880 specialty (psychiatric, long-term care, and rehabilitation)
hospitals, and 340 federal (military, veterans, and Native
American) hospitals, or 2.7 hospitals per 100,000 population.
2. In 1990, the average length of stay for 33 million admissions was 9.2 days.
The bed occupancy rate was 66%. Lengths of stay were shorter and admission rates
lower than other countries.
3. In 1990, the US had 615,000 physicians, or 2.4 per 1,000 population; 33% were
primary care (family medicine, internal medicine, and pediatrics) and 67% were
specialists.
4. In 1991, government-run health care spending totaled $81 billion.
5. Total US health care spending rose to $752 billion in 1991 from $70 billion
in 1950. Spending grew five-fold per capita.
6. Reasons for increased healthcare spending include:
7. The high cost of defensive medicine, with an escalation in services solely
to avoid malpractice litigation.
8. US health care based on defensive medicine costs nearly $45 billion per year,
or about 5% of total health care spending, according to one source.
9. The availability and use of new medical technologies have contributed the
most to increased health care spending, argue many analysts. These costs are
impossible to quantify.
10. The reasons government attempts to control health care costs have failed
include:
11. Market incentive and profit-motive involvement in the financing and organization
of health care, including private insurers, hospital systems, physicians, and
the drug and medical-device industries.
12. Expansion is the goal of free enterprise. |
Health-Related Research
and Development
| |
1. The US spends more than any other country on
health-related R&D.
2. In 1989, the federal government spent $9.2 billion on R&D, while private
industry spent an additional $9.4 billion.
3. Total US R&D expenditures rose 50% from 1983 to 1992.
4. NIH receives about half of US government R&D funding.
5. NIH spent more on basic research ($4.1 billion in 1989) than for clinical
trials of medical treatments on humans ($519 million in 1989).
6. Most of the clinical trials evaluate new treatment protocols for cancer and
complications of AIDS, and do not study existing treatments, even though their
effectiveness is in many cases unknown and questionable.
7. In 1990, the NIH had just begun to do meta-analysis and cost-effectiveness
analysis. |
Pharmaceutical
and Medical-Device Industries
| |
1. About two-thirds of the industry's $9.4 billion
budget went to drug research; device manufacturers spent the
remaining one-third.
2. In addition to R&D, the medical industry spent 24% of total sales on promoting
their products and 15% of total sales on development.
3. Total marketing expenses in 1990 were over $5 billion.
4. Many products provide no benefit over existing products.
5. Public and private health care consumers buy these products.
6. If health care spending is perceived as a problem, a highly profitable drug
industry exacerbates the problem.
Controlling Health Care Technology
1. The FDA ensures the safety and efficacy of drugs, biologics, and medical devices.
2. The FDA does not consider costs of therapy.
3. The FDA does not consider the effectiveness of a therapy.
4. The FDA does not compare a product to currently marketed products
5. The FDA does not consider nondrug alternatives for a given clinical problem.
6. It costs $200 million in development costs to bring a new drug to market.
AIDS-drug interest groups forced new regulations that speed up the approval process.
7. Such drugs should be subject to greater post-marketing surveillance requirements.
As of 1995, these provisions had not yet come into play.
8. Many argue that reductions in the pre-approval testing of drugs open the possibility
of significant undiscovered toxicities. |
Health Care Technology
Assessment
| |
1. 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%).
2. In 1978, Congress created the National Center for Health Care Technology (NCHCT)
to advise Medicare and Medicaid.
3. With an annual budget of $4 million, NCHCT published three broad assessments
of high-priority technologies and made about 75 coverage recommendations to Medicare.
4. Congress disbanded NCHCT in 1981. 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.”
5. The medical device lobby also opposed government oversight by NCHCT. |
Examples of Lack
of Proper Management
of
HealthCare
Treatments for
Coronary Artery
Disease
| |
1. Since the early 1970s, the number of coronary artery bypass surgeries (CABGS)
has risen rapidly without government regulation or clinical trials.
2. Angioplasty for single vessel disease was introduced in 1978. The first published
trial of angioplasty versus medical treatment was done in 1992.
3. Angioplasty did not reduce the number of CABGS, as was promoted.
4. Both procedures increase in number every year as the patient population grows
older and sicker.
5. Rates of use are higher in white patients and private insurance patients,
and vary greatly by geographic region, suggesting that use of these procedures
is based on non-clinical factors.
6. As of 1995, the NIH consensus program had not assessed CABGS since 1980 and
had never assessed angioplasty.
7. RAND researchers evaluated CABGS in New York in 1990. They reviewed 1,300
procedures and found 2% were inappropriate, 90% were appropriate, and 7% were
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 US 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 of the national average.
8. The estimated five-year cost is $33,000 for angioplasty and $40,000 for CABGS.
Angioplasty did not lower costs, due to its high failure rates. |
Computed Tomography
(CT)
| |
1. The first CT scanner in the US was installed
at the Mayo Clinic in 1973. By 1992, the number of operational
CT scanners in the US had grown to 6,060. By comparison, in 1993
there were 216 CT units in Canada.
2. There is little information available on how CT scans improve or affect patient
outcomes
3. In some institutions, up to 90% of scans performed were negative.
4. Approval by the FDA was not required for CT scanners, nor was any evidence
of safety or efficacy. |
Magnetic
Resonance
Imaging (MRI)
| |
1. MRIs were introduced in Great Britain in 1978
and in the US in 1980. By 1988, there were 1,230 units and by
1992 between 2,800 and 3,000.
2. A definitive review published in 1994 found less than 30 studies of 5,000
that were prospective comparisons of diagnostic accuracy or therapeutic choice.
3. The American College of Physicians assessed MRI studies and rated 13 of 17
trials as “weak,” i.e., lacking data concerning therapeutic impact
or patient outcomes.
4. The OTA concluded: “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 forces.” |
Laparoscopic
Surgery
| |
1. Laparoscopic cholecystectomy was introduced
at a professional surgical society meeting in late 1989. By 1992,
85% of all cholecystectomies were performed laparoscopically.
2. There was an associated increase of 30% in the number of cholecystectomies
performed.
3. Because of the increased volume of gall bladder operations, their total cost
increased 11.4% between 1988 and 1992, despite a 25.1% drop in the average cost
per surgery.
4. The mortality rate for gall bladder surgeries did not decline as a result
of the lower risk because so many more were performed.
5. When studies were finally done on completed cases, the results showed that
laparoscopic cholecystectomy was associated with reduced inpatient duration,
decreased pain, and a shorter period of restricted activity. But rates of bile
duct and major vessel injury increased and it was suggested that these rates
were worse for people with acute cholecystitis. No clinical trials had been done
to clarify this issue.
6. Patient demand, fueled by substantial media attention, was a major force in
promoting rapid adoption of these procedures.
7. The major manufacturer of laparoscopic equipment produced the video that introduced
the procedure in 1989.
8. Doctors were given two-day training seminars before performing the surgery
on patients. |
Infant
Mortality
| |
1. In 1990, the US ranked 24th in infant mortality
of 38 developed countries with a rate of 9.2 deaths per 1,000
live births.
2. US black infant mortality is 18.6 per 1,000 live births, compared to 8.8 for
whites. |
Screening
for
Breast
Cancer
| |
1. Mammography screening in women under 50 has
always been a subject of debate.
2. In 1992, the Canadian National Breast Cancer Study of 50,000 women showed
that mammography had no effect on mortality for women aged 40-50.
3. The National Cancer Institute (NCI) refused to change its recommendations
on mammography.
4. The American Cancer Society decided to wait for more studies on mammography.
5. In December 1993, NCI announced that women over 50 should have routine screenings
every one to two years but that younger women would derive no benefit from mammography. |
Summary
| |
1. The OTA concluded: “There are no mechanisms in place to limit dissemination
of technologies regardless of their clinical value.”
Shortly after the release of this report, the OTA was disbanded. |
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