Death by Medicine

By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora
Rasio, MD; and Dorothy Smith, PhD

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.

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)
In16.4 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

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 (R) 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.

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

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).
Overuse of antibiotics for all conditions.
Carcinogenic drugs (hormone replacement therapy,* immunosuppressive
and prescription drugs).
Cancer chemotherapy(70)
Surgery and unnecessary surgery (cesarean section, radical mastectomy,
preventive mastectomy, radical hysterectomy, prostatectomy,
cholecystectomies, cosmetic surgery, arthroscopy, etc.).
Discredited medical procedures and therapies.
Unproven medical therapies.
Outpatient surgery.
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.

OFFICE OF TECHNOLOGY ASSESSMENT (OTA)

Health Care Technology and Its Assessment in Eight Countries, 1995.

General Facts
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.
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.
Health status is correlated with socioeconomic status.
Health care is not universal.
Health care is based on the free market system with no fixed budget or
limitations on expansion.
Health care accounts for 14% of the US GNP ($800 billion in 1993).
The federal government does no central planning, though it is the
major purchaser of health care for older people and some poor people.
Americans are less satisfied with their health care system than people
in other developed countries.
US medicine specializes in expensive medical technology; some large US
cities have more magnetic resonance image (MRI) scanners than most
countries.
Huge public and private investments in medical research and
pharmaceutical development drive this "technological arms race."
Any efforts to restrain technological developments in health care are
opposed by policymakers concerned about negative impacts on medical-
technology industries.
Hospitals
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.
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.
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.
In 1991, government-run health care spending totaled $81 billion.
Total US health care spending rose to $752 billion in 1991 from $70
billion in 1950. Spending grew five-fold per capita.
Reasons for increased healthcare spending include:
The high cost of defensive medicine, with an escalation in services
solely to avoid malpractice litigation.
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.
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.
The reasons government attempts to control health care costs have
failed include:
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.
Expansion is the goal of free enterprise.
Health-Related Research and Development

The US spends more than any other country on health-related R&D.
In 1989, the federal government spent $9.2 billion on R&D, while
private industry spent an additional $9.4 billion.
Total US R&D expenditures rose 50% from 1983 to 1992.
NIH receives about half of US government R&D funding.
NIH spent more on basic research ($4.1 billion in 1989) than for
clinical trials of medical treatments on humans ($519 million in
1989).
Most of the 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.
In 1990, the NIH had just begun to do meta-analysis and cost-
effectiveness analysis.
Pharmaceutical and Medical-Device Industries
About two-thirds of the industry's $9.4 billion budget went to drug
research; device manufacturers spent the remaining one-third.
In addition to R&D, the medical industry spent 24% of total sales on
promoting their products and 15% of total sales on development.
Total marketing expenses in 1990 were over $5 billion.
Many products provide no benefit over existing products.
Public and private health care consumers buy these products.
If health care spending is perceived as a problem, a highly profitable
drug industry exacerbates the problem.
Controlling Health Care Technology
The FDA ensures the safety and efficacy of drugs, biologics, and
medical devices.
The FDA does not consider costs of therapy.
The FDA does not consider the effectiveness of a therapy.
The FDA does not compare a product to currently marketed products
The FDA does not consider nondrug alternatives for a given clinical
problem.
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.
Such drugs should be subject to greater post-marketing surveillance
requirements. As of 1995, these provisions had not yet come into
play.
Many argue that reductions in the pre-approval testing of drugs open
the possibility of significant undiscovered toxicities.
Health Care Technology Assessment
Failure to evaluate technology was a focus of a 1978 report from OTA
with examples of many common medical practices supported by limited
published data (10-20%).
In 1978, Congress created the National Center for Health Care
Technology (NCHCT) to advise Medicare and Medicaid.
With an annual budget of $4 million, NCHCT published three broad
assessments of high-priority technologies and made about 75 coverage
recommendations to Medicare.
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."
The medical device lobby also opposed government oversight by NCHCT.
Examples of Lack of Proper Management of HealthCare

Treatments for Coronary Artery Disease

Since the early 1970s, the number of coronary artery bypass surgeries
(CABGS) has risen rapidly without government regulation or clinical
trials.
Angioplasty for single vessel disease was introduced in 1978. The
first published trial of angioplasty versus medical treatment was done
in 1992.
Angioplasty did not reduce the number of CABGS, as was promoted.
Both procedures increase in number every year as the patient
population grows older and sicker.
Rates of use are higher in white patients and private insurance
patients, and vary greatly by geographic region, suggesting that use
of these procedures is based on non-clinical factors.
As of 1995, the NIH consensus program had not assessed CABGS since
1980 and had never assessed angioplasty.
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.
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)
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 .
There is little information available on how CT scans improve or
affect patient outcomes
In some institutions, up to 90% of scans performed were negative.
Approval by the FDA was not required for CT scanners, nor was any
evidence of safety or efficacy.
Magnetic Resonance Imaging (MRI)
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.
A definitive review published in 1994 found less than 30 studies of
5,000 that were prospective comparisons of diagnostic accuracy or
therapeutic choice.
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.
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
Laparoscopic cholecystectomy was introduced at a professional surgical
society meeting in late 1989. By 1992, 85% of all cholecystectomies
were performed laparoscopically.
There was an associated increase of 30% in the number of
cholecystectomies performed.
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.
The mortality rate for gall bladder surgeries did not decline as a
result of the lower risk because so many more were performed.
When studies were finally done on completed cases, the results showed
that laparoscopic cholecystectomy was associated with reduced
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.
Patient demand, fueled by substantial media attention, was a major
force in promoting rapid adoption of these procedures.
The major manufacturer of laparoscopic equipment produced the video
that introduced the procedure in 1989.
Doctors were given two-day training seminars before performing the
surgery on patients.
Infant Mortality
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.
US black infant mortality is 18.6 per 1,000 live births, compared to
8.8 for whites.
Screening for Breast Cancer
Mammography screening in women under 50 has always been a subject of
debate.
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.
The National Cancer Institute (NCI) refused to change its
recommendations on mammography.
The American Cancer Society decided to wait for more studies on
mammography.
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
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.

References

All Contents Copyright (c) 1995-2008 Life Extension Foundation
The complete article with references:
www.lef.org