Death by Medicine
Are the Deadly Facts Intentionally Suppressed to Protect Profits and Power?
With These Truths and Facts, You Decide
By: Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD
Rev. 11/14/2013
Something is wrong when regulatory agencies pretend that vitamins are dangerous,
yet ignore scientifically established and published facts showing that government-sanctioned medicine is
the real danger.
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. These researchers have authored a paper titled “Death
by Medicine” that presents compelling evidence that today’s medical 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)
We placed this article on our website to memorialize the failure of the American
medical system. By exposing these gruesome statistics in painstaking detail, we
provide a basis for competent and compassionate medical professionals to
recognize the inadequacies of today’s system and at least attempt to institute
meaningful reforms.
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 non-profit 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 (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, they 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 favourable 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, in 1996 published Tainted Truth : The Manipulation of Fact in
America , a book about the widespread practice of lying with statistics.(22) Commenting on
the state of scientific research, she 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® 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. Egger 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.
Egger 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. Egger 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. Egger says that
exposure to a steady stream of antibiotics has altered pathogens such as
Streptococcus pneumoniae, Staplococcus aureus, and entercocci,
to name a few.
Almost half of patients with upper respiratory tract infections in the U.S. still
receive antibiotics from their 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 anaesthetic 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 1987JAMA 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.
Death
by Medicine (Appendix)
By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD;
and Dorothy Smith, PhD
(175) 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.
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LE Magazine, March 2004
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