VITAL - Death by Medicine, Part I (Part II in separate email)

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Death by Medicine, Part I

By Null PhD, Carolyn Dean MD ND,

Feldman MD, Debora Rasio MD, Dorothy PhD

ABSTRACT

A definitive review and close reading of medical

peer-review journals, and government health

statistics shows that American medicine

frequently causes more harm than good. The number

of people having in-hospital, adverse drug

reactions (ADR) to prescribed medicine is 2.2

million.1 Dr. Besser, of the CDC, in

1995, said the number of unnecessary antibiotics

prescribed annually for viral infections was 20

million. Dr. Besser, in 2003, now refers to tens

of millions of unnecessary antibiotics.2, 2a

The number of unnecessary medical and surgical

procedures performed annually is 7.5 million.3

The number of people exposed to unnecessary

hospitalization annually is 8.9 million.4 The

total number of iatrogenic deaths shown in the

following table is 783,936. It is evident that

the American medical system is the leading cause

of death and injury in the United States. The

2001 heart disease annual death rate is 699,697;

the annual cancer death rate, 553,251.5

TABLES AND FIGURES (see Section on Statistical

Tables and Figures, below, for exposition)

ANNUAL PHYSICAL AND ECONOMIC COST OF MEDICAL INTERVENTION

Condition Deaths Cost Author

Adverse Drug Reactions 106,000 $12 billion Lazarou1 Suh49

Medical error 98,000 $2 billion IOM6

Bedsores 115,000 $55 billion Xakellis7 Barczak8

Infection 88,000 $5 billion Weinstein9 MMWR10

Malnutrition 108,800 -------- Nurses Coalition11

Outpatients 199,000 $77 billion Starfield12 Weingart112

Unnecessary Procedures 37,136 $122 billion HCUP3,13

Surgery-Related 32,000 $9 billion AHRQ85

TOTAL

783,936 $282 billion

We could have an even higher death rate by using

Dr. Lucien Leape’s 1997 medical and drug error

rate of 3 million. 14 Multiplied by the fatality

rate of 14% (that Leape used in 199416 we arrive

at an annual death rate of 420,000 for drug

errors and medical errors combined. If we put

this number in place of Lazorou’s 106,000 drug

errors and the Institute of Medicine’s (IOM)

98,000 medical errors, we could add another

216,000 deaths making a total of 999,936 deaths annually.

Condition Deaths Cost Author

ADR/med error 420,000 $200 billion Leape 199714

TOTAL

999,936

ANNUAL UNNECESSARY MEDICAL EVENTS STATISTICS

Unnecessary Events People Affected Iatrogenic Events

Hospitalization 8.9 million4 1.78 million16

Procedures 7.5 million3 1.3 million40

TOTAL

16.4 million 3.08 million

The enumerating of unnecessary medical events is

very important in our analysis. Any medical

procedure that is invasive and not necessary must

be considered as part of the larger iatrogenic

picture. Unfortunately, cause and effect go

unmonitored. The figures on unnecessary events

represent people (“patients”) who are thrust into

a dangerous healthcare system. They are helpless

victims. Each one of these 16.4 million lives is

being affected in a way that could have a fatal

consequence. Simply entering a hospital could result in the following:

In 16.4 million people, 2.1% chance of a serious

adverse drug reaction,1 (186,000)

In 16.4 million people, 5-6% chance of acquiring

a nosocomial infection,9 (489,500)

In16.4 million people, 4-36% chance of having an

iatrogenic injury in hospital (medical error and

adverse drug reactions),16 (1.78 million)

In 16.4 million people, 17% chance of a procedure error,40 (1.3 million)

All the statistics above represent a one-year

time span. Imagine the numbers over a ten-year

period. Working with the most conservative

figures from our statistics we project the following 10-year death rates.

TEN-YEAR DEATH RATES FOR MEDICAL INTERVENTION

Condition 10-Year Deaths Author

Adverse Drug Reaction 1.06 million (1)

Medical error 0.98 million (6)

Bedsores 1.15 million (7,8)

Nosocomial Infection 0.88 million (9,10)

Malnutrition 1.09 million (11)

Outpatients 1.99 million (12, 112)

Unnecessary Procedures 371,360 (3,13)

Surgery-related 320,000 (85)

TOTAL

7,841,360 (7.8 million)

Our projected statistic of 7.8 million iatrogenic

deaths is more than all the casualties from wars

that America has fought in its entire history.

Our projected figures for unnecessary medical

events occurring over a 10-year period are also dramatic.

TEN-YEAR STATISTICS FOR UNNECESSARY INTERVENTION

Unnecessary Events 10-year Number Iatrogenic Events

Hospitalization 89 million4 17 million

Procedures 75 million3 15 million

TOTAL

164 million

These projected figures show that a total of 164

million people, approximately 56% of the

population of the United States, have been

treated unnecessarily by the medical industry ­

in other words, nearly 50,000 people per day.

INTRODUCTION

Never before have the complete statistics on the

multiple causes of iatrogenesis been combined in

one paper. Medical science amasses tens of

thousands of papers annually--each one a tiny

fragment of the whole picture. To look at only

one piece and try to understand the benefits and

risks is to stand one inch away from an elephant

and describe everything about it. You have to

pull back to reveal the complete picture, such as

we have done here. Each specialty, each division

of medicine, keeps their own records and data on

morbidity and mortality like pieces of a puzzle.

But the numbers and statistics were always hiding

in plain sight. We have now completed the

painstaking work of reviewing thousands and

thousands of studies. Finally putting the puzzle

together we came up with some disturbing answers.

Is American Medicine Working?

At 14 percent of the Gross National Product,

health care spending reached $1.6 trillion in

2003.15 Considering this enormous expenditure, we

should have the best medicine in the world. We

should be reversing disease, preventing disease,

and doing minimal harm. However, careful and

objective review shows the opposite. Because of

the extraordinary narrow context of medical

technology through which contemporary medicine

examines the human condition, we are completely missing the full picture.

Medicine is not taking into consideration the

following monumentally important aspects of a

healthy human organism: (a) stress and how it

adversely affects the immune system and life

processes; ( insufficient exercise; ©

excessive caloric intake; (d) highly-processed

and denatured foods grown in denatured and

chemically-damaged soil; and (e) exposure to tens

of thousands of environmental toxins. Instead of

minimizing these disease-causing factors, we

actually cause more illness through medical

technology, diagnostic testing, overuse of

medical and surgical procedures, and overuse of

pharmaceutical drugs. The huge disservice of this

therapeutic strategy is the result of little

effort or money being appropriated for preventing disease.

Under-reporting of Iatrogenic Events

As few as 5 percent and only up to 20 percent of

iatrogenic acts are ever reported.16,24,25,33,34

This implies that if medical errors were

completely and accurately reported, we would have

a much higher annual iatrogenic death rate than

783,936. Dr. Leape, in 1994, said his figure of

180,000 medical mistakes annually was equivalent

to three jumbo-jet crashes every two days.16 Our

report shows that six jumbo jets are falling out of the sky each and every day.

Correcting a Compromised System

What we must deduce from this report is that

medicine is in need of complete and total reform:

from the curriculum in medical schools to

protecting patients from excessive medical

intervention. It is quite obvious that we can’t

change anything if we are not honest about what

needs to be changed. This report simply shows the

degree to which change is required.

We are fully aware that what stands in the way of

change are powerful pharmaceutical companies,

medical technology companies, and special

interest groups with enormous vested interests in

the business of medicine. They fund medical

research, support medical schools and hospitals,

and advertise in medical journals. With deep

pockets they entice scientists and academics to

support their efforts. Such funding can sway the

balance of opinion from professional caution to

uncritical acceptance of a new therapy or drug.

You only have to look at the number of invested

people on hospital, medical, and government

health advisory boards to see conflict of

interest. The public is mostly unaware of these

interlocking interests. For example, a 2003 study

found that nearly half of medical school faculty,

who serve on Institutional Review Boards (IRB) to

advise on clinical trial research, also serve as

consultants to the pharmaceutical industry.17 The

authors were concerned that such representation

could cause potential conflicts of interest.

A news release by Dr. , 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

Quick, director of Essential Drugs and

Medicines Policy for the World Health

Organization (WHO) wrote in a recent WHO

Bulletin: " If clinical trials become a commercial

venture in which self-interest overrules public

interest and desire overrules science, then the

social contract which allows research on human

subjects in return for medical advances is broken. " 19

Former editor of the New England Journal of

Medicine (NEJM), Dr. Marcia Angell, struggled to

bring the attention of the world to the problem

of commercializing scientific research in her

outgoing editorial titled “Is Academic Medicine

for Sale?”20 Angell called for stronger

restrictions on pharmaceutical stock ownership

and other financial incentives for researchers.

She said that growing conflicts of interest are tainting science.

She warned that, “When the boundaries between

industry and academic medicine become as blurred

as they are now, the business goals of industry

influence the mission of medical schools in

multiple ways.” She did not discount the benefits

of research but said a Faustian bargain now

existed between medical schools and the pharmaceutical industry.

Angell left the NEMJ in June 2000. Two years

later, in June 2002, the NEJM announced that it

would now accept biased journalists (those who

accept money from drug companies) because it is

too difficult to find ones who have no ties.

Another former editor of the journal, Dr. Jerome

Kassirer, said that was just not the case, that

there are plenty of researchers who don’t work

for drug companies.21 The ABC report said that

one measurable tie between pharmaceutical

companies and doctors amounts to over $2 billion

a year spent for over 314,000 events that doctors attend.

The ABC report also noted that a survey of

clinical trials revealed that when a drug company

funds a study, there is a 90 percent chance that

the drug will be perceived as effective whereas a

non-drug company-funded study will show favorable

results 50 percent of the time. It appears that

money can’t buy you love but it can buy you any

" scientific " result you want. The only safeguard

to reporting these studies was if the journal

writers remained unbiased. That is no longer the case.

Crossen, writer for the Wall Street

Journal in 1996, published Tainted Truth: The

Manipulation of Fact in America, a book about the

widespread practice of lying with statistics.22

Commenting on the state of scientific research

she said that, “The road to hell was paved with

the flood of corporate research dollars that

eagerly filled gaps left by slashed government

research funding.” Her data on financial

involvement showed that in l981 the drug industry

“gave” $292 million to colleges and universities

for research. In l991 it “gave” $2.1 billion.

THE FIRST IATROGENIC STUDY

Dr. Lucian L. Leape opened medicine’s Pandora’s

box in his 1994 JAMA paper, “Error in

Medicine”.16 He began the paper by reminiscing

about Florence Nightingale’s maxim--“first do no

harm.” But he found evidence of the opposite

happening in medicine. He found that Schimmel

reported in 1964 that 20 percent of hospital

patients suffered iatrogenic injury, with a 20

percent fatality rate. Steel in 1981 reported

that 36 percent of hospitalized patients

experienced iatrogenesis with a 25 percent

fatality rate and adverse drug reactions were

involved in 50 percent of the injuries. Bedell in

1991 reported that 64 percent of acute heart

attacks in one hospital were preventable and were

mostly due to adverse drug reactions.

However, Leape focused on his and Brennan’s

“Harvard Medical Practice Study” published in

1991.16a They found that in 1984, in New York

State, there was a 4 percent iatrogenic injury

rate for patients with a 14 percent fatality

rate. From the 98,609 patients injured and the 14

percent fatality rate, he estimated that in the

whole of the U.S. 180,000 people die each year,

partly as a result of iatrogenic injury. Leape

compared these deaths to the equivalent of three

jumbo-jet crashes every two days.

Why Leape chose to use the much lower figure of

four percent injury for his analysis remains in

question. Perhaps he wanted to tread lightly. If

Leape had, instead, calculated the average rate

among the three studies he cites (36 percent, 20

percent, and 4 percent), he would have come up

with a 20 percent medical error rate. The number

of fatalities that he could have presented, using

an average rate of injury and his 14 percent

fatality, is an annual 1,189,576 iatrogenic

deaths, or over ten jumbo jets crashing every day.

Leape acknowledged that the literature on medical

error is sparse and we are only seeing the tip of

the iceberg. He said that when errors are

specifically sought out, reported rates are

“distressingly high”. He cited several autopsy

studies with rates as high as 35 percent to 40

percent of missed diagnoses causing death. He

also commented that an intensive care unit

reported an average of 1.7 errors per day per

patient, and 29 percent of those errors were

potentially serious or fatal. We wonder: what is

the effect on someone who daily gets the wrong

medication, the wrong dose, the wrong procedure;

how do we measure the accumulated burden of

injury; and when the patient finally succumbs

after the tenth error that week, what is entered on the death certificate?

Leape calculated the rate of error in the

intensive care unit. First, he found that each

patient had an average of 178 “activities”

(staff/procedure/medical interactions) a day, of

which 1.7 were errors, which means a 1 percent

failure rate. To some this may not seem like

much, but putting this into perspective, Leape

cited industry standards where in aviation a 0.1

percent failure rate would mean 2 unsafe plane

landings per day at O’Hare airport; in the U.S.

Mail, 16,000 pieces of lost mail every hour; or

in banking, 32,000 bank checks deducted from the

wrong bank account every hour.

Analyzing why there is so much medical error

Leape acknowledged the lack of reporting. Unlike

a jumbo-jet crash, which gets instant media

coverage, hospital errors are spread out over the

country in thousands of different locations. They

are also perceived as isolated and unusual

events. However, the most important reason that

medical error is unrecognized and growing,

according to Leape, was, and still is, that

doctors and nurses are unequipped to deal with

human error, due to the culture of medical training and practice.

Doctors are taught that mistakes are

unacceptable. Medical mistakes are therefore

viewed as a failure of character and any error

equals negligence. We can see how a great deal of

sweeping under the rug takes place since nobody

is taught what to do when medical error does

occur. Leape cited McIntyre and Popper who said

the “infallibility model” of medicine leads to

intellectual dishonesty with a need to cover up

mistakes rather than admit them. There are no

Grand Rounds on medical errors, no sharing of

failures among doctors and no one to support them

emotionally when their error harms a patient.

Leape hoped his paper would encourage medicine

“to fundamentally change the way they think about

errors and why they occur”. It’s been almost a

decade since this groundbreaking work, but the mistakes continue to soar.

One year later, in 1995, a report in JAMA said

that, " Over a million patients are injured in

U.S. hospitals each year, and approximately

280,000 die annually as a result of these

injuries. Therefore, the iatrogenic death rate

dwarfs the annual automobile accident mortality

rate of 45,000 and accounts for more deaths than

all other accidents combined. " 23

At a press conference in 1997 Dr. Leape released

a nationwide poll on patient iatrogenesis

conducted by the National Patient Safety

Foundation (NPSF), which is sponsored by the

American Medical Association. The survey found

that more than 100 million Americans have been

impacted directly and indirectly by a medical

mistake. Forty-two percent were directly affected

and a total of 84 percent personally knew of

someone who had experienced a medical mistake.14

Dr. Leape is a founding member of the NPSF.

Dr. Leape at this press conference also updated

his 1994 statistics saying that medical errors in

inpatient hospital settings nationwide, as of

1997, could be as high as three million and could

cost as much as $200 billion. Leape used a 14

percent fatality rate to determine a medical

error death rate of 180,000 in 1994.16 In 1997,

using Leape’s base number of three million

errors, the annual deaths could be as much as

420,000 for inpatients alone. This does not

include nursing home deaths, or people in the

outpatient community dying of drug side effects

or as the result of medical procedures.

ONLY A FRACTION OF MEDICAL ERRORS ARE REPORTED

Leape, in 1994, said that he was well aware that

medical errors were not being reported.16

According to a study in two obstetrical units in

the U.K., only about one quarter of the adverse

incidents on the units are ever reported for

reasons of protecting staff or preserving

reputations, or fear of reprisals, including law

suits.24 An analysis by Wald and Shojania found

that only 1.5 percent of all adverse events

result in an incident report, and only 6 percent

of adverse drug events are identified properly.

The authors learned that the American College of

Surgeons gives a very broad guess that surgical

incident reports routinely capture only 5-30

percent of adverse events. In one surgical study

only 20 percent of surgical complications

resulted in discussion at Morbidity and Mortality

Rounds.25 From these studies it appears that all

the statistics that are gathered may be

substantially underestimating the number of

adverse drug and medical therapy incidents. It

also underscores the fact that our mortality

statistics are actually conservative figures.

An article in Psychiatric Times outlines the

stakes involved with reporting medical errors.26

They found that the public is fearful of

suffering a fatal medical error, and doctors are

afraid they will be sued if they report an error.

This brings up the obvious question: who is

reporting medical errors? Usually it is the

patient or the patient’s surviving family. If no

one notices the error, it is never reported.

Janet Heinrich, an associate director at the U.S.

General Accounting Office responsible for health

financing and public health issues, testifying

before a House subcommittee about medical errors,

said that, " The full magnitude of their threat to

the American public is unknown.” She added,

" Gathering valid and useful information about

adverse events is extremely difficult. " She

acknowledged that the fear of being blamed, and

the potential for legal liability, played key

roles in the under-reporting of errors. The

Psychiatric Times noted that the American Medical

Association is strongly opposed to mandatory

reporting of medical errors.26 If doctors aren’t

reporting, what about nurses? In a survey of

nurses, they also did not report medical mistakes for fear of retaliation.27

Standard medical pharmacology texts admit that

relatively few doctors ever report adverse drug

reactions to the FDA.28 The reasons range from

not knowing such a reporting system exists to

fear of being sued because they prescribed a drug

that caused harm. 29 However, it is this

tremendously flawed system of voluntary reporting

from doctors that we depend on to know whether a

drug or a medical intervention is harmful.

Pharmacology texts will also tell doctors how

hard it is to separate drug side effects from

disease symptoms. Treatment failure is most often

attributed to the disease and not the drug or the

doctor. Doctors are warned, “Probably nowhere

else in professional life are mistakes so easily

hidden, even from ourselves.”30 It may be hard to

accept, but not difficult to understand, why only

one in twenty side effects is reported to either

hospital administrators or the FDA.31,31a

If hospitals admitted to the actual number of

errors and mistakes, which is about 20 times what

is reported, they would come under intense

scrutiny.32 Jerry , associate director of

the Office of Post Marketing Drug Risk Assessment

at the FDA, confirms this number. “In the broader

area of adverse drug reaction data, the 250,000

reports received annually probably represent only

five percent of the actual reactions that

occur.”33 Dr. Jay Cohen, who has extensively

researched adverse drug reactions, comments that

because only five percent of adverse drug

reactions are being reported, there are, in

reality, five million medication reactions each year.34

It remains that whatever figure you choose to

believe about the side effects from drugs, all

the experts agree that you have to multiply that

by 20 to get a more accurate estimate of what is

really occurring in the burgeoning “field” of iatrogenic medicine.

A 2003 survey is all the more distressing because

there seems to be no improvement in

error-reporting even with all the attention on

this topic. Dr. Dorothea Wild surveyed medical

residents at a community hospital in Connecticut.

She found that only half of the residents were

aware that the hospital had a medical

error-reporting system, and the vast majority

didn’t use it at all. Dr. Wild says this does not

bode well for the future. If doctors don’t learn

error-reporting in their training, they will

never use it. And she adds that error reporting

is the first step in finding out where the gaps

in the medical system are and fixing them. That

first baby step has not even begun.35

PUBLIC SUGGESTIONS ON IATROGENESIS

In a telephone survey, 1,207 adults were asked to

indicate how effective they thought the following

would be in reducing preventable medical errors

that resulted in serious harm:36

giving doctors more time to spend with patients: very effective 78 percent

requiring hospitals to develop systems to avoid

medical errors: very effective 74 percent

better training of health professionals: very effective 73 percent

using only doctors specially trained in intensive

care medicine on intensive care units: very effective 73 percent

requiring hospitals to report all serious medical

errors to a state agency: very effective 71 percent

increasing the number of hospital nurses: very effective 69 percent

reducing the work hours of doctors-in-training to

avoid fatigue: very effective 66 percent

encouraging hospitals to voluntarily report

serious medical errors to a state agency: very effective 62 percent

DRUG IATROGENESIS

Drugs comprise the major treatment modality of

scientific medicine. With the discovery of the

“Germ Theory” medical scientists convinced the

public that infectious organisms were the cause

of illness. Finding the “cure” for these

infections proved much harder than anyone

imagined. From the beginning, chemical drugs

promised much more than they delivered. But far

beyond not working, the drugs also caused

incalculable side effects. The drugs themselves,

even when properly prescribed, have side effects

that can be fatal, as Lazarou’s study1 shows. But

human error can make the situation even worse.

Medication Errors

A survey of a 1992 national pharmacy database

found a total of 429,827 medication errors from

1,081 hospitals. Medication errors occurred in

5.22 percent of patients admitted to these

hospitals each year. The authors concluded that a

minimum of 90,895 patients annually were harmed

by medication errors in the country as a whole.37

A 2002 study shows that 20 percent of hospital

medications for patients had dosage mistakes.

Nearly 40 percent of these errors were considered

potentially harmful to the patient. In a typical

300-patient hospital the number of errors per day were 40.38

Problems involving patients’ medications were

even higher the following year. The error rate

intercepted by pharmacists in this study was 24

percent, making the potential minimum number of

patients harmed by prescription drugs 417,908.39

Recent Adverse Drug Reactions

More recent studies on adverse drug reactions

show that the figures from 1994 (published in

Lazarou’s 1998 JAMA article) may be increasing. A

2003 study followed 400 patients after discharge

from a tertiary care hospital (hospital care that

requires highly specialized skills, technology or

support services). Seventy-six patients (19

percent) had adverse events. Adverse drug events

were the most common at 66 percent. The next most

common events were procedure-related injuries at 17 percent.40

In a NEJM study an alarming one-in-four patients

suffered observable side effects from the more

than 3.34 billion prescription drugs filled in

2002.41 One of the doctors who produced the study

was interviewed by Reuters and commented that,

" With these 10-minute appointments, it's hard for

the doctor to get into whether the symptoms are

bothering the patients. " 42 Tierney, who

editorialized on the NEJM study, said “… given

the increasing number of powerful drugs available

to care for the aging population, the problem will only get worse.”

The drugs with the worst record of side effects

were the SSRIs, the NSAIDs, and calcium-channel

blockers. Reuters also reported that prior

research has suggested that nearly five percent

of hospital admissions--over 1 million per

year--are the result of drug side effects. But

most of the cases are not documented as such. The

study found one of the reasons for this failure:

in nearly two-thirds of the cases, doctors

couldn’t diagnose drug side effects or the side

effects persisted because the doctor failed to heed the warning signs.

Medicating Our Feelings

We only need to look at the side effects of

antidepressant drugs, which give hope to a

depressed population. Patients seeking a more

joyful existence and relief from worry, stress

and anxiety, fall victim to the messages

blatantly displayed on TV and billboards. Often,

instead of relief, they also fall victim to a

myriad of iatrogenic side effects of antidepressant medication.

Also, a whole generation of antidepressant users

has resulted from young people growing up on

Ritalin. Medicating youth and modifying their

emotions must have some impact on how they learn

to deal with their feelings. They learn to equate

coping with drugs and not their inner resources.

As adults, these medicated youth reach for

alcohol, drugs, or even street drugs, to cope.

According to the Journal of the American Medical

Association, “Ritalin acts much like cocaine.”43

Today’s marketing of mood-modifying drugs, such

as Prozac or Zoloft, makes them not only socially

acceptable but almost a necessity in today’s stressful world.

Television Diagnosis

In order to reach the widest audience possible,

drug companies are no longer just targeting

medical doctors with their message about

antidepressants. By 1995 drug companies had

tripled the amount of money allotted to direct

advertising of prescription drugs to consumers.

The majority of the money is spent on seductive

television ads. From 1996 to 2000, spending rose

from $791 million to nearly $2.5 billion.44 Even

though $2.5 billion may seem like a lot of money,

the authors comment that it only represents 15

percent of the total pharmaceutical advertising budget.

According to medical experts “there is no solid

evidence on the appropriateness of prescribing

that results from consumers requesting an

advertised drug.” However, the drug companies

maintain that direct-to-consumer advertising is

educational. Dr. Sidney M. Wolfe, of the Public

Citizen Health Research Group in Washington,

D.C., argues that the public is often misinformed

about these ads.45 People want what they see on

television and are told to go to their doctor for a prescription.

Doctors in private practice either acquiesce to

their patients’ demands for these drugs or spend

valuable clinic time trying to talk patients out

of unnecessary drugs. Dr. Wolfe remarks that one

important study found that people mistakenly

believe that the “FDA reviews all ads before they

are released and allows only the safest and most

effective drugs to be promoted directly to the public.”46

How Do We Know Drugs Are Safe?

Another aspect of scientific medicine that the

public takes for granted is the testing of new

drugs. Unlike the class of people that take drugs

who are ill and need medication, in general,

drugs are tested on individuals who are fairly

healthy and not on other medications that can

interfere with findings. But when they are

declared “safe” and enter the drug prescription

books, they are naturally going to be used by

people on a variety of other medications and who

also have a lot of other health problems.

Then, a new Phase of drug testing called

Post-Approval comes into play, which is the

documentation of side effects once drugs hit the

market. In one very telling report, the General

Accounting Office (an agency of the U.S.

Government) " found that of the 198 drugs approved

by the FDA between 1976 and 1985 … 102 (or 51.5

percent) had serious post-approval risks … the

serious post-approval risks (included) heart

failure, myocardial infarction, anaphylaxis,

respiratory depression and arrest, seizures,

kidney and liver failure, severe blood disorders,

birth defects and fetal toxicity, and blindness. " 47

The investigative show NBC’s “Dateline” wondered

if your doctor is moonlighting as a drug rep.

After a year-long investigation they reported

that because doctors can legally prescribe any

drug to any patient for any condition, drug

companies heavily promote " off-label " and

frequently inappropriate and non-tested uses of

these medications in spite of the fact that these

drugs are only approved for specific indications they have been tested for.48

The leading causes of adverse drug reactions are

antibiotics (17 percent), cardiovascular drugs

(17 percent), chemotherapy (15 percent), and

analgesics and anti-inflammatory agents (15 percent).49

Specific Drug Iatrogenesis: Antibiotics

Dr. Egger, in a recent editorial, wrote that

after 50 years of increasing use of antibiotics,

30 million pounds of antibiotics are used in

America per year.50 Twenty-five million pounds of

this total are used in animal husbandry. The vast

majority of this amount, 23 million pounds, is

used to try to prevent disease, the stress of

shipping, and to promote growth. Only 2 million

pounds are given for specific animal infections.

Dr. Egger reminds us that low concentrations of

antibiotics are measurable in many of our foods,

rivers, and streams around the world. Much of

this is seeping into bodies of water from animal farms.

Egger says overuse of antibiotics results in

food-borne infections resistant to antibiotics.

Salmonella is found in 20 percent of ground meat

but constant exposure of cattle to antibiotics

has made 84 percent of salmonella resistant to at

least one anti-salmonella antibiotic. Diseased

animal food accounts for 80 percent of

salmonellosis in humans, or 1.4 million cases per year.

The conventional approach to dealing with this

epidemic is to radiate food to try to kill all

organisms but keep using the antibiotics that

cause the original problem. Approximately 20

percent of chickens are contaminated with

Campylobacter jejuni causing 2.4 million human

cases of illness annually. Fifty-four percent of

these organisms are resistant to at least one anti-campylobacter antimicrobial.

A ban on growth-promoting antibiotics in Denmark

began in 1999, which led to a decrease from

453,200 pounds to 195,800 pounds within a year.

Another report from Scandinavia found that taking

away antibiotic growth promoters had no or

minimal effect on food production costs. Egger

further warns that in America the current

crowded, unsanitary methods of animal farming

support constant stress and infection, and are

geared toward high antibiotic use. He says these

conditions would have to be changed along with cutting back on antibiotic use.

In America, over 3 million pounds of antibiotics

are used every year on humans. With a population

of 284 million Americans, this amount is enough

to give every man, woman and child 10 teaspoons

of pure antibiotics per year. Egger says that

exposure to a steady stream of antibiotics has

altered pathogens such as Streptococcus

pneumoniae, Staplococcus aureus, and entercocci, to name a few.

Almost half of patients with upper respiratory

tract infections in the United States still

receive antibiotics from their doctor.51

According to the CDC, 90 percent of upper

respiratory infections are viral and should not

be treated with antibiotics. In Germany the

prevalence for systemic antibiotic use in

children aged 0 to 6 years was 42.9 percent.52

Data taken from nine U.S. health plans between

1996 and 2000 on antibiotic use in 25,000

children found that rates of antibiotic use

decreased. Antibiotic use in children, aged 3

months to under 3 years, decreased 24 percent,

from 2.46 to 1.89 antibiotic prescriptions

per/patient per/year. For children, 3 years to

under 6 years, there was a 25 percent reduction

from 1.47 to 1.09 antibiotic prescriptions

per/patient per/year. And for children aged 6 to

under 18 years, there was a 16 percent reduction

from 0.85 to 0.69 antibiotic prescriptions per/

patient /per year.53 Although there was a

reduction in antibiotic use, the data indicate

that on average every child in America receives

1.22 antibiotic prescriptions annually.

Group A beta-hemolytic streptococci is the only

common cause of sore throat that requires

antibiotics, penicillin and erythromycin being

the only recommended treatment. However, 90

percent of sore throats are viral. The authors of

this study estimated there were 6.7 million adult

annual visits for sore throat between 1989 and

1999 in the United States. Antibiotics were used

in 73 percent of visits. Furthermore, patients

treated with antibiotics were given

non-recommended broad-spectrum antibiotics in 68 percent of visits.

The authors noted, that from 1989 to 1999, there

was a significant increase in the newer and more

expensive broad-spectrum antibiotics and a

decrease in use of penicillin and erythromycin,

which are the recommended antibiotics.54 If

antibiotics were given in 73 percent of visits

and should have only been given in 10 percent,

this represents 63 percent, or a total of 4.2

million visits for sore throat that ended in

unnecessary antibiotic prescriptions between1989

and 1999. In 1995, Dr. Besser and the CDC cited

2003 cited much higher figures of 20 million

unnecessary antibiotic prescriptions per year for

viral infections.2 Neither of these figures takes

into account the number of unnecessary

antibiotics used for non-fatal conditions such as

acne, intestinal infection, skin infections, ear infections, etc.

The Problem with Antibiotics: They are Anti-Life

On September 17, 2003 the CDC relaunched a

program, started in 1995, called “Get Smart: Know

When Antibiotics Work.”55 This is a $1.6 million

campaign to educate patients about the overuse

and inappropriate use of antibiotics. Most people

involved with alternative medicine have known

about the dangers of overuse of antibiotics for

decades. Finally the government is focusing on

the problem, yet they are only putting a

miniscule amount of money into an iatrogenic

epidemic that is costing billions of dollars and thousands of lives.

The CDC warns that 90 percent of upper

respiratory infections, including children’s ear

infections, are viral, and antibiotics don’t

treat viral infection. More than 40 percent of

about 50 million prescriptions for antibiotics

each year in physicians' offices were

inappropriate.2 And using antibiotics, when not

needed, can lead to the development of deadly

strains of bacteria that are resistant to drugs

and cause more than 88,000 deaths due to hospital-acquired infections.9

However, the CDC seems to be blaming patients for

misusing antibiotics even though they are only

available on prescription from a doctor who

should know how to prescribe properly. Dr.

Besser, head of “Get Smart,” says

" Programs that have just targeted physicians have

not worked. Direct-to-consumer advertising of

drugs is to blame in some cases.” Dr. Besser says

the program “teaches patients and the general

public that antibiotics are precious resources

that must be used correctly if we want to have

them around when we need them. Hopefully, as a

result of this campaign, patients will feel more

comfortable asking their doctors for the best

care for their illnesses, rather than asking for antibiotics. " 56

And what does the “best care” constitute? The CDC

does not elaborate and patently avoids the latest

research on the dozens of nutraceuticals

scientifically proven to treat viral infections

and boost the immune system. Will their doctors

recommend vitamin C, echinacea, elderberry,

vitamin A, zinc, or homeopathic oscillococcinum?

No, they won’t. The archaic solutions offered by

the CDC include a radio ad, “Just Say No--Snort,

sniffle, sneeze--No antibiotics please. " Their

commonsense recommendations, that most people do

anyway, include resting, drinking plenty of fluids, and using a humidifier.

The pharmaceutical industry claims they are all

for limiting the use of antibiotics. In order to

make sure that happens, the drug company Bayer is

sponsoring a program called, “Operation Clean

Hands,” through an organization called LIBRA.57

The CDC is also involved with trying to minimize

antibiotic resistance, but nowhere in their

publications is there any reference to the role

of nutraceuticals in boosting the immune system

nor to the thousands of journal articles that support this approach.

This recalcitrant tunnel vision and refusal to

use available non-drug alternatives is absolutely

inappropriate when the CDC is desperately trying

to curb the nightmare of overuse of antibiotics.

The CDC should also be called to task because it

is only focusing on the overuse of antibiotics.

There are similar nightmares for every class of drug being prescribed today.

Drugs Pollute Our Water Supply

We have reached the point of saturation with

prescription drugs. We have arrived at the point

where every body of water tested contains

measurable drug residues. We are inundated with

drugs. The tons of antibiotics used in animal

farming, which run off into the water table and

surrounding bodies of water, are conferring

antibiotic resistance to germs in sewage, and

these germs are also found in our water supply.

Flushed down our toilets are tons of drugs and

drug metabolites that also find their way into

our water supply. We have no idea what the

long-term consequences of ingesting a mixture of

drugs and drug-breakdown products will do to our

health. It’s another level of iatrogenic disease

that we are unable to completely measure.58-67

Specific Drug Iatrogenesis: NSAIDs

It’s not just America that is plagued with

iatrogenesis. A survey of 1,072 French general

practitioners (GPs) tested their basic

pharmacological knowledge and practice in

prescribing NSAIDs. Non-steroidal

anti-inflammatory drugs (NSAIDs) rank first among

commonly prescribed drugs for serious adverse

reactions. The results of the study suggested

that GPs don’t have adequate knowledge of these

drugs and are unable to effectively manage adverse reactions.68

A cross-sectional survey of 125 patients

attending specialty pain clinics in South London

found that possible iatrogenic factors such as

“over-investigation, inappropriate information,

and advice given to patients as well as

misdiagnosis, over-treatment, and inappropriate

prescription of medication were common.”69

Specific Drug Iatrogenesis: Cancer Chemotherapy

In 1989, a German biostatistician, Ulrich Abel

PhD, after publishing dozens of papers on cancer

chemotherapy, wrote a monograph “Chemotherapy of

Advanced Epithelial Cancer.” It was later

published in a shorter form in a peer-reviewed

medical journal.70 Dr. Abel presented a

comprehensive analysis of clinical trials and

publications representing over 3,000 articles

examining the value of cytotoxic chemotherapy on

advanced epithelial cancer. Epithelial cancer is

the type of cancer we are most familiar with. It

arises from epithelium found in the lining of

body organs such as breast, prostate, lung, stomach, or bowel.

From these sites cancer usually infiltrates into

adjacent tissue and spreads to bone, liver, lung,

or the brain. With his exhaustive review Dr. Abel

concludes that there is no direct evidence that

chemotherapy prolongs survival in patients with

advanced carcinoma. He said that in small-cell

lung cancer and perhaps ovarian cancer the

therapeutic benefit is only slight. Dr. Abel goes

on to say, “Many oncologists take it for granted

that response to therapy prolongs survival, an

opinion which is based on a fallacy and which is

not supported by clinical studies.”

Over a decade after Dr. Abel’s exhaustive review

of chemotherapy, there seems no decrease in its

use for advanced carcinoma. For example, when

conventional chemotherapy and radiation has not

worked to prevent metastases in breast cancer,

high-dose chemotherapy (HDC) along with stem-cell

transplant (SCT) is the treatment of choice.

However, in March 2000, results from the largest

multi-center randomized controlled trial

conducted thus far showed that, compared to a

prolonged course of monthly conventional-dose

chemotherapy, HDC and SCT were of no benefit.71

There was even a slightly lower survival rate for

the HDC/SCT group. And the authors noted that

serious adverse effects occurred more often in

the HDC group than the standard-dose group. There

was one treatment-related death (within 100 days

of therapy) in the HDC group, but none in the

conventional chemotherapy group. The women in

this trial were highly selected as having the best chance to respond.

There is also no all-encompassing follow-up study

like Dr. Abel’s that tells us if there is any

improvement in cancer-survival statistics since

1989. In fact, we need to research whether

chemotherapy itself is responsible for secondary

cancers instead of progression of the original

disease. We continue to question why

well-researched alternative cancer treatments aren’t used.

Drug Companies Fined

Periodically, a drug manufacturer is fined by the

FDA when the abuses are too glaring and

impossible to cover up. The May 2002 Washington

Post reported that the maker of Claritin,

Schering-Plough Corp., was to pay a $500 million

fine to the FDA for quality-control problems at

four of its factories.72 The FDA tabulated

infractions that included 90 percent, or 125 of

the drugs they made since 1998. Besides the fine,

the company had to stop manufacturing 73 drugs or

suffer another $175 million fine. PR statements

by the company told another story. The company

assured consumers that they should still feel confident in its products.

Such a large settlement serves as a warning to

the drug industry about maintaining strict

manufacturing practices and has given the FDA

more clout in dealing with drug company

compliance. According to the Washington Post

article, a federal appeals court ruled in 1999

that the FDA could seize the profits of companies

that violate " good manufacturing practices. "

Since that time Abbott Laboratories Inc. paid

$100 million for failing to meet quality

standards in the production of medical test kits,

and Wyeth Laboratories Inc. paid $30 million in

2000 to settle accusations of poor manufacturing practices.

The indictment against Schering-Plough came after

the Public Citizen Health Research Group, lead by

Dr. Sidney Wolfe, called for a criminal

investigation of Schering-Plough, charging that

the company distributed albuterol asthma inhalers

even though it knew the units were missing the active ingredient.

UNNECESSARY SURGICAL PROCEDURES

Summary:

1974: 2.4 million unnecessary surgeries performed

annually resulting in 11,900 deaths at an annual cost of $3.9 billion.73,74

2001: 7.5 million unnecessary surgical procedures

resulting in 37,136 deaths at a cost of $122 billion (using 1974 dollars).3

It’s very difficult to obtain accurate statistics

when studying unnecessary surgery. Dr. Leape in

1989 wrote that perhaps 30 percent of

controversial surgeries are unnecessary.

Controversial surgeries include Cesarean section,

tonsillectomy, appendectomy, hysterectomy,

gastrectomy for obesity, breast implants, and elective breast implants.74

Almost 30 years ago, in 1974, the Congressional

Committee on Interstate and Foreign Commerce held

hearings on unnecessary surgery. They found that

17.6 percent of recommendations for surgery were

not confirmed by a second opinion. The House

Subcommittee on Oversight and Investigations

extrapolated these figures and estimated that, on

a nationwide basis, there were 2.4 million

unnecessary surgeries performed annually,

resulting in 11,900 deaths at an annual cost of $3.9 billion.73

In 2001, the top 50 medical and surgical

procedures totaled approximately 41.8 million.

These figures were taken from the Healthcare Cost

and Utilization Project within the Agency for

Healthcare Research and Quality.13 Using 17.6

percent from the 1974 U.S. Congressional House

Subcommittee Oversight Investigation as the

percentage of unnecessary surgical procedures,

and extrapolating from the death rate in 1974, we

come up with an unnecessary procedure number of

7.5 million (7,489,718) and a death rate of

37,136, at a cost of $122 billion (using 1974 dollars).

Researchers performed a very similar analysis,

using the 1974 ‘unnecessary surgery percentage’

of 17.6, on back surgery. In 1995, researchers

testifying before the Department of Veterans

Affairs estimated that of 250,000 back surgeries

in the U.S. at a hospital cost of $11,000 per

patient, the total number of unnecessary back

surgeries each year in the U.S. could approach

44,000, costing as much as $484 million.75

The unnecessary surgery figures are escalating

just as prescription drugs driven by television

advertising. Media-driven surgery such as gastric

bypass for obesity “modeled” by Hollywood

personalities seduces obese people to think this

route is safe and sexy. There is even a problem

of surgery being advertised on the Internet.76 A

study in Spain declares that between 20 percent

and 25 percent of total surgical practice represents unnecessary operations.77

According to data from the National Center for

Health Statistics from 1979 to 1984, there was a

nine percent increase in the total number of

surgical procedures, and the number of surgeons

grew by 20 percent. The author notes that there

has not been a parallel increase in the number of

surgeries despite a recent large increase in the

number of surgeons. There was concern that there

would be too many surgeons to share a small surgical caseload.78

The previous author spoke too soon--there was no

cause to worry about a small surgical caseload.

By 1994, there was an increase of 38 percent for

a total of 7,929,000 cases for the top ten

surgical procedures. In 1983, surgical cases

totaled 5,731,000. In 1994, cataract surgery was

number one with over two million operations, and

second was Cesarean section (858,000 procedures).

Inguinal hernia operations were third (689,000

procedures), and knee arthroscopy, in seventh

place, grew 153 percent (632,000 procedures)

while prostate surgery declined 29 percent (229,000 procedures).79

The list of iatrogenic diseases from surgery is

as long as the list of procedures themselves. In

one study epidural catheters were inserted to

deliver anesthetic into the epidural space around

the spinal nerves to block them for lower

Cesarean section, abdominal surgery, or prostate

surgery. In some cases, non-sterile technique,

during catheter insertion, resulted in serious

infections, even leading to limb paralysis.80

In one review of the literature, the authors

demonstrated “a significant rate of

overutilization of coronary angiography, coronary

artery surgery, cardiac pacemaker insertion,

upper gastrointestinal endoscopies, carotid

endarterectomies, back surgery, and pain-relieving procedures.”81

A 1987 JAMA study found the following significant

levels of inappropriate surgery: 17 percent of

cases for coronary angiography, 32 percent for

carotid endarterectomy, and 17 percent for upper

gastrointestinal tract endoscopy.82 Using the

Healthcare Cost and Utilization Project (HCUP)

statistics provided by the government for 2001,

the number of people getting upper

gastrointestinal endoscopy, which usually entails

biopsy, was 697,675; the number getting

endarterectomy was 142,401; and the number having

coronary angiography was 719,949.13 Therefore,

according to the JAMA study 17 percent, or

118,604 people had an unnecessary endoscopy

procedure. Endarterectomy occurred in 142,401

patients; potentially 32 percent or 45,568 did

not need this procedure. And 17 percent of

719,949, or 122,391 people receiving coronary

angiography were subjected to this highly

invasive procedure unnecessarily. These are all forms of medical iatrogenesis.

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PART II to follow