DEATH BY MEDICINE - READ THIS, IF YOU VALUE LIFE AND HEALTH

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Death by Medicine

Something is wrong when regulatory agencies pretend that vitamins are

dangerous, yet ignore published statistics showing that

government-sanctioned medicine is the real hazard.

Until now, Life Extension could cite only isolated statistics to make

its

case about the dangers of conventional medicine. No one had ever

analyzed

and combined ALL of the published literature dealing with injuries and

deaths caused by government-protected medicine. That has now changed.

A group of researchers meticulously reviewed the statistical evidence

and

their findings are absolutely shocking.4 These researchers have authored

a

paper titled Death by Medicine that presents compelling evidence that

today's system frequently causes more harm than good.

This fully referenced report shows the number of people having

in-hospital,

adverse reactions to prescribed drugs to be 2.2 million per year. The

number

of unnecessary antibiotics prescribed annually for viral infections is

20

million per year. The number of unnecessary medical and surgical

procedures

performed annually is 7.5 million per year. The number of people exposed

to

unnecessary hospitalization annually is 8.9 million per year.

The most stunning statistic, however, is that the total number of deaths

caused by conventional medicine is an astounding 783,936 per year. It is

now

evident that the American medical system is the leading cause of death

and

injury in the US. (By contrast, the number of deaths attributable to

heart

disease in 2001 was 699,697, while the number of deaths attributable to

cancer was 553,251.5)

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.

Death by Medicine

By Null, PhD; Carolyn Dean MD, ND; Feldman, MD; Debora

Rasio, MD

and Dorothy , PhD

Natural medicine is under siege, as pharmaceutical company lobbyists

urge

lawmakers to deprive Americans of the benefits of dietary supplements.

Drug-company front groups have launched slanderous media campaigns to

discredit the value of healthy lifestyles. The FDA continues to

interfere

with those who offer natural products that compete with prescription

drugs.

These attacks against natural medicine obscure a lethal problem that

until

now was buried in thousands of pages of scientific text. In response to

these baseless challenges to natural medicine, the Nutrition Institute

of

America commissioned an independent review of the quality of

" government-approved " medicine. The startling findings from this

meticulous

study indicate that conventional medicine is " the leading cause of

death " in

the United States .

The Nutrition Institute of America is a nonprofit organization that has

sponsored independent research for the past 30 years. To support its

bold

claim that conventional medicine is America 's number-one killer, the

Nutritional Institute of America mandated that every " count " in this

" indictment " of US medicine be validated by published, peer-reviewed

scientific studies.

What you are about to read is a stunning compilation of facts that

documents

that those who seek to abolish consumer access to natural therapies are

misleading the public. Over 700,000 Americans die each year at the hands

of

government-sanctioned medicine, while the FDA and other government

agencies

pretend to protect the public by harassing those who offer safe

alternatives

A definitive review of medical peer-reviewed journals and government

health

statistics shows that American medicine frequently causes more harm than

good.

Each year approximately 2.2 million US hospital patients experience

adverse

drug reactions (ADRs) to prescribed medications.(1) In 1995, Dr.

Besser of the federal Centers for Disease Control and Prevention (CDC)

estimated the number of unnecessary antibiotics prescribed annually for

viral infections to be 20 million; in 2003, Dr. Besser spoke in terms of

tens of millions of unnecessary antibiotics prescribed annually.(2, 2a)

Approximately 7.5 million unnecessary medical and surgical procedures

are

performed annually in the US,(3) while approximately 8.9 million

Americans

are hospitalized unnecessarily.(4)

As shown in the following table, the estimated total number of

iatrogenic

deaths-that is, deaths induced inadvertently by a physician or surgeon

or by

medical treatment or diagnostic procedures- in the US annually is

783,936.

It is evident that the American medical system is itself the leading

cause

of death and injury in the US [Emphasis added. G.] . By comparison,

approximately 699,697 Americans died of heart in 2001, while 553,251

died of

cancer.(5)

The enumerating of unnecessary medical events is very important in our

analysis. Any invasive, unnecessary medical procedure must be considered

as

part of the larger iatrogenic picture. Unfortunately, cause and effect

go

unmonitored. The figures on unnecessary events represent people who are

thrust into a dangerous health care system. Each of these 16.4 million

lives

is being affected in ways that could have fatal consequences. Simply

entering a hospital could result in the following:

* In 16.4 million people, a 2.1% chance (affecting 186,000) of a serious

adverse drug reaction(1)

* In 16.4 million people, a 5-6% chance (affecting 489,500) of acquiring

a nosocomial infection(9)

* In 16.4 million people, a 4-36% chance (affecting 1.78 million) of

having an iatrogenic injury (medical error and adverse drug

reactions).(16)

* In 16.4 million people, a 17% chance (affecting 1.3 million) of a

procedure error.(40)

These statistics represent a one-year time span. Working with the most

conservative figures from our statistics, we project the following

10-year

death rates.

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; ( 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 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. , 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)

As former editor of the New England Journal of Medicine , Dr. Marcia

Angell

struggled to bring greater attention to the problem of commercializing

scientific research. In her outgoing editorial entitled Is Academic

Medicine for Sale? Angell said that growing conflicts of interest are

tainting science and called for stronger restrictions on pharmaceutical

stock ownership and other financial incentives for researchers:(20)

" When

the boundaries between industry and academic medicine become as blurred

as

they are now, the business goals of industry influence the mission of

medical schools in multiple ways. " She did not discount the benefits of

research but said a Faustian bargain now existed between medical schools

and

the pharmaceutical industry.

Angell left the New England Journal in June 2000. In June 2002, the New

England Journal of Medicine announced that it would accept journalists

who

accept money from drug companies because it was too difficult to find

ones

who have no ties. Another former editor of the journal, Dr. Jerome

Kassirer,

said that was not the case and that plenty of researchers are available

who

do not work for drug companies.(21) According to an ABC news report,

pharmaceutical companies spend over $2 billion a year on over 314,000

events

attended by doctors.

The ABC news report also noted that a survey of clinical trials revealed

that when a drug company funds a study, there is a 90% chance that the

drug

will be perceived as effective whereas a non-drug-company-funded study

will

show favorable results only 50% of the time. It appears that money can't

buy

you love but it can buy any " scientific " result desired.

Crossen, a staffer for the Wall Street Journal, i n 1996

published

Tainted Truth : The Manipulation of Fact in America , a book about the

widespread practice of lying with statistics.(22) Commenting on the

state of

scientific research, she wrote: " The road to hell was paved with the

flood

of corporate research dollars that eagerly filled gaps left by slashed

government research funding. " Her data on financial involvement showed

that

in l981 the drug industry " gave " $292 million to colleges and

universities

for research. By l991, this figure had risen to $2.1 billion.

THE FIRST IATROGENIC STUDY

Dr. Lucian L. Leape opened medicine's Pandora's box in his 1994 paper,

" Error in Medicine, " which appeared in the Journal of the American

Medical

Association (JAMA).(16) He found that Schimmel reported in 1964 that 20%

of

hospital patients suffered iatrogenic injury, with a 20% fatality rate.

In

1981 Steel reported that 36% of hospitalized patients experienced

iatrogenesis with a 25% fatality rate, and adverse drug reactions were

involved in 50% of the injuries. In 1991, Bedell reported that 64% of

acute

heart attacks in one hospital were preventable and were mostly due to

adverse drug reactions.

Leape focused on the " Harvard Medical Practice Study " published in 1991,

(16a) which found a 4% iatrogenic injury rate for patients, with a 14%

fatality rate, in 1984 in New York State. From the 98,609 patients

injured

and the 14% fatality rate, he estimated that in the entire U.S. 180,000

people die each year partly as a result of iatrogenic injury.

Why Leape chose to use the much lower figure of 4% injury for his

analysis

remains in question. Using instead the average of the rates found in the

three studies he cites (36%, 20%, and 4%) would have produced a 20%

medical

error rate. The number of iatrogenic deaths using an average rate of

injury

and his 14% fatality rate would be 1,189,576.

Leape acknowledged that the literature on medical errors is sparse and

represents only the tip of the iceberg, noting that when errors are

specifically sought out, reported rates are " distressingly high. " He

cited

several autopsy studies with rates as high as 35-40% of missed diagnoses

causing death. He also noted that an intensive care unit reported an

average

of 1.7 errors per day per patient, and 29% of those errors were

potentially

serious or fatal.

Leape calculated the error rate in the intensive care unit study. First,

he

found that each patient had an average of 178 " activities "

(staff/procedure/medical interactions) a day, of which 1.7 were errors,

which means a 1% failure rate. This may not seem like much, but Leape

cited

industry standards showing that in aviation, a 0.1% failure rate would

mean

two unsafe plane landings per day at Chicago's O'Hare International

Airport;

in the US Postal Service, a 0.1% failure rate would mean 16,000 pieces

of

lost mail every hour; and in the banking industry, a 0.1% failure rate

would

mean 32,000 bank checks deducted from the wrong bank account.

In trying to determine why there are so many medical errors, Leape

acknowledged the lack of reporting of medical errors. Medical errors

occur

in thousands of different locations and are perceived as isolated and

unusual events. But the most important reason that the problem of

medical

errors is unrecognized and growing, according to Leape, is that doctors

and

nurses are unequipped to deal with human error because of the culture of

medical training and practice. Doctors are taught that mistakes are

unacceptable. Medical mistakes are therefore viewed as a failure of

character and any error equals negligence. No one is taught what to do

when

medical errors do occur. Leape cites McIntyre and Popper, who said the

" infallibility model " of medicine leads to intellectual dishonesty with

a

need to cover up mistakes rather than admit them. There are no Grand

Rounds

on medical errors, no sharing of failures among doctors, and no one to

support them emotionally when their error harms a patient.

Leape hoped his paper would encourage medical practitioners " to

fundamentally change the way they think about errors and why they

occur. " It

has been almost a decade since this groundbreaking work, but the

mistakes

continue to soar.

In 1995, a JAMA report noted, " Over a million patients are injured in US

hospitals each year, and approximately 280,000 die annually as a result

of

these injuries. Therefore, the iatrogenic death rate dwarfs the annual

automobile accident mortality rate of 45,000 and accounts for more

deaths

than all other accidents combined. " (23)

At a 1997 press conference, Leape released a nationwide poll on patient

iatrogenesis conducted by the National Patient Safety Foundation (NPSF),

which is sponsored by the American Medical Association (AMA). Leape is a

founding member of NPSF. The survey found that more than 100 million

Americans have been affected directly or indirectly by a medical

mistake.

Forty-two percent were affected directly and 84% personally knew of

someone

who had experienced a medical mistake.(14)

At this press conference, Leape updated his 1994 statistics, noting that

as

of 1997, medical errors in inpatient hospital settings nationwide could

be

as high as 3 million and could cost as much as $200 billion . Leape used

a

14% fatality rate to determine a medical error death rate of 180,000 in

1994

(16) In 1997, using Leape's base number of 3 million errors, the annual

death rate could be as high as 420,000 for hospital inpatients alone.

ONLY A FRACTION OF MEDICAL ERRORS ARE REPORTED

In 1994, Leape said he was well aware that medical errors were not being

reported.(16) A study conducted in two obstetrical units in the UK found

that only about one-quarter of adverse incidents were ever reported, to

protect staff, preserve reputations, or for fear of reprisals, including

lawsuits.(24). An analysis by Wald and Shojania found that only 1.5% of

all

adverse events result in an incident report, and only 6% of adverse drug

events are identified properly. The authors learned that the American

College of Surgeons estimates that surgical incident reports routinely

capture only 5-30% of adverse events. In one study, only 20% of surgical

complications resulted in discussion at morbidity and mortality

rounds.(25)

From these studies, it appears that all the statistics gathered on

medical

errors may substantially underestimate the number of adverse drug and

medical therapy incidents. They also suggest that our statistics

concerning

mortality resulting from medical errors may be in fact be conservative

figures.

An article in Psychiatric Times (April 2000) outlines the stakes

involved in

reporting medical errors.(26) The authors found that the public is

fearful

of suffering a fatal medical error, and doctors are afraid they will be

sued

if they report an error. This brings up the obvious question: who is

reporting medical errors? Usually it is the patient or the patient's

surviving family. If no one notices the error, it is never reported.

Janet

Heinrich, an associate director at the U.S. General Accounting Office

responsible for health financing and public health issues, testified

before

a House subcommittee hearing on medical errors that " the full magnitude

of

their threat to the American public is unknown " and " gathering valid and

useful information about adverse events is extremely difficult. " She

acknowledged that the fear of being blamed, and the potential for legal

liability, played key roles in the underreporting of errors. The

Psychiatric

Times noted that the AMA strongly opposes mandatory reporting of medical

errors.(26) If doctors are not reporting, what about nurses? A survey of

nurses found that they also fail to report medical mistakes for fear of

retaliation.(27)

Standard medical pharmacology texts admit that relatively few doctors

ever

report adverse drug reactions to the FDA.(28) The reasons range from not

knowing such a reporting system exists to fear of being sued.(29) Yet

the

public depends on this tremendously flawed system of voluntary reporting

by

doctors to know whether a drug or a medical intervention is harmful.

Pharmacology texts also will tell doctors how hard it is to separate

drug

side effects from disease symptoms. Treatment failure is most often

attributed to the disease and not the drug or doctor. Doctors are

warned,

" Probably nowhere else in professional life are mistakes so easily

hidden...

What constitutes the " best care " ? The CDC does not elaborate and ignores

the

latest research on the dozens of nutraceuticals that have been

scientifically proven to treat viral infections and boost immune-system

function. Will doctors recommend vitamin C, Echinacea, elderberry,

vitamin A

zinc, or homeopathic oscillococcinum? Probably not. The CDC's

common-sense

recommendations that most people follow anyway include getting proper

rest,

drinking plenty of fluids, and using a humidifier.

The pharmaceutical industry claims it supports limiting the use of

antibiotics. The drug company Bayer sponsors a program called " Operation

Clean Hands " through an organization called LIBRA.(57) The CDC also is

involved in trying to minimize antibiotic resistance, but nowhere in its

publications is there any reference to the role of nutraceuticals in

boosting the immune system, nor to the thousands of journal articles

that

support this approach. This tunnel vision and refusal to recommend the

available non-drug alternatives is unfortunate when the CDC is

desperately

trying to curb the overuse of antibiotics.

Drugs Pollute Our Water Supply

We have reached the point of saturation with prescription drugs. Every

body

of water tested contains measurable drug residues. The tons of

antibiotics

used in animal farming, which run off into the water table and

surrounding

bodies of water, are conferring antibiotic resistance to germs in

sewage,

and these germs also are found in our water supply. Flushed down our

toilets

are tons of drugs and drug metabolites that also find their way into our

water supply. We have no way to know the long-term health consequences

of

ingesting a mixture of drugs and drug-breakdown products. These drugs

represent another level of iatrogenic disease that we are unable to

completely measure.(58-67)

Specific Drug Iatrogenesis: NSAIDs

It's not just the US that is plagued by iatrogenesis. A survey of more

than

1,000 French general practitioners (GPs) tested their basic

pharmacological

knowledge and practice in prescribing NSAIDs, which rank first among

commonly prescribed drugs for serious adverse reactions. The study

results

suggest that GPs do not have adequate knowledge of these drugs and are

unable to effectively manage adverse reactions.(68)

A cross-sectional survey of 125 patients attending specialty pain

clinics in

South London found that possible iatrogenic factors such as

" over-investigation, inappropriate information, and advice given to

patients

as well as misdiagnosis, over-treatment, and inappropriate prescription

of

medication were common. " (69)

Specific Drug Iatrogenesis: Cancer Chemotherapy

In 1989, German biostatistician Ulrich Abel, PhD, wrote a monograph

entitled

" Chemotherapy of Advanced Epithelial Cancer. " It was later published in

shorter form in a peer-reviewed medical journal.(70) Abel presented a

comprehensive analysis of clinical trials and publications representing

over

3,000 articles examining the value of cytotoxic chemotherapy on advanced

epithelial cancer. Epithelial cancer is the type of cancer with which we

are

most familiar, arising from epithelium found in the lining of body

organs

such as the breast, prostate, lung, stomach, and bowel. From these

sites,

cancer usually infiltrates adjacent tissue and spreads to the bone,

liver,

lung, or brain. With his exhaustive review, Abel concluded there is no

direct evidence that chemotherapy prolongs survival in patients with

advanced carcinoma; in small-cell lung cancer and perhaps ovarian

cancer,

the therapeutic benefit is only slight. According to Abel, " Many

oncologists

take it for granted that response to therapy prolongs survival, an

opinion

which is based on a fallacy and which is not supported by clinical

studies. "

Over a decade after Abel's exhaustive review of chemotherapy, there

seems no

decrease in its use for advanced carcinoma. For example, when

conventional

chemotherapy and radiation have not worked to prevent metastases in

breast

cancer, high-dose chemotherapy (HDC) along with stem-cell transplant

(SCT)

is the treatment of choice. In March 2000, however, results from the

largest

multi-center randomized controlled trial conducted thus far showed that,

compared to a prolonged course of monthly conventional-dose

chemotherapy,

HDC and SCT were of no benefit, (71) with even a slightly lower survival

rate for the HDC/SCT group. Serious adverse effects occurred more often

in

the HDC group than the standard-dose group. One treatment-related death

(within 100 days of therapy) was recorded in the HDC group, but none was

recorded in the conventional chemotherapy group. The women in this trial

were highly selected as having the best chance to respond.

Unfortunately, no all-encompassing follow-up study such as Dr. Abel's

exists

to indicate whether there has been any improvement in cancer-survival

statistics since 1989. In fact, research should be conducted to

determine

whether chemotherapy itself is responsible for secondary cancers instead

of

progression of the original disease. We continue to question why

well-researched alternative cancer treatments are not used.

Drug Companies Fined

Periodically, the FDA fines a drug manufacturer when its abuses are too

glaring and impossible to cover up. In May 2002, The Washington Post

reported that Schering-Plough Corp., the maker of Claritin, was to pay a

$500 million dollar fine to the FDA for quality-control problems at four

of

its factories.(72) The indictment came after the Public Citizen Health

Research Group, led by Dr. Sidney Wolfe, called for a criminal

investigation

of Schering-Plough, charging that the company distributed albuterol

asthma

inhalers even though it knew the units were missing the active

ingredient.

The FDA tabulated infractions involving 125 products, or 90% of the

drugs

made by Schering-Plough since 1998. Besides paying the fine, the company

was

forced to halt the manufacture of 73 drugs or suffer another $175

million

fine. Schering-Plough's news releases told another story, assuring

consumers

that they should still feel confident in the company's products.

This large settlement served as a warning to the drug industry about

maintaining strict manufacturing practices and has given the FDA more

clout

in dealing with drug company compliance. According to The Washington

Post

article, a federal appeals court ruled in 1999 that the FDA could seize

the

profits of companies that violate " good manufacturing practices. " Since

that

time, Abbott Laboratories has paid a $100 million fine for failing to

meet

quality standards in the production of medical test kits, while Wyeth

Laboratories paid $30 million in 2000 to settle accusations of poor

manufacturing practices.

UNNECESSARY SURGICAL PROCEDURES

In 1974, 2.4 million unnecessary surgeries were performed, resulting in

11

900 deaths at a cost of $3.9 billion.(73,74) In 2001, 7.5 million

unnecessary surgical procedures were performed, resulting in 37,136

deaths

at a cost of $122 billion (using 1974 dollars).(3)

It is very difficult to obtain accurate statistics when studying

unnecessary

surgery. In 1989, Leape wrote that perhaps 30% of controversial

surgeries-which include cesarean section, tonsillectomy, appendectomy,

hysterectomy, gastrectomy for obesity, breast implants, and elective

breast

implants(74)- are unnecessary. In 1974, the Congressional Committee on

Interstate and Foreign Commerce held hearings on unnecessary surgery. It

found that 17.6% of recommendations for surgery were not confirmed by a

second opinion. The House Subcommittee on Oversight and Investigations

extrapolated these figures and estimated that, on a nationwide basis,

there

were 2.4 million unnecessary surgeries performed annually, resulting in

11

900 deaths at an annual cost of $3.9 billion.(73)

According to the Healthcare Cost and Utilization Project within the

Agency

for Healthcare Research and Quality(13), in 2001 the 50 most common

medical

and surgical procedures were performed approximately 41.8 million times

in

the US. Using the 1974 House Subcommittee on Oversight and

Investigations'

figure of 17.6% as the percentage of unnecessary surgical procedures,

and

extrapolating from the death rate in 1974, produces nearly 7.5 million

(7

489,718) unnecessary procedures and a death rate of 37,136, at a cost of

$122 billion (using 1974 dollars).

In 1995, researchers conducted a similar analysis of back surgery

procedures

using the 1974 " unnecessary surgery percentage " of 17.6. Testifying

before

the Department of Veterans Affairs, they estimated that of the 250,000

back

surgeries performed annually in the US at a hospital cost of $11,000 per

patient, the total number of unnecessary back surgeries approaches

44,000,

costing as much as $484 million.(75)

Like prescription drug use driven by television advertising, unnecessary

surgeries are escalating. Media-driven surgery such as gastric bypass

for

obesity " modeled " by Hollywood celebrities seduces obese people to think

this route is safe and sexy. Unnecessary surgeries have even been

marketed

on the Internet.(76) A study in Spain declares that 20-25% of total

surgical

practice represents unnecessary operations.(77)

According to data from the National Center for Health Statistics for

1979 to

1984, the total number of surgical procedures increased 9% while the

number

of surgeons grew 20%. The study notes that the large increase in the

number

of surgeons was not accompanied by a parallel increase in the number of

surgeries performed, and expressed concern about an excess of surgeons

to

handle the surgical caseload.(78)

From 1983 to 1994, however, the incidence of the 10 most commonly

performed

surgical procedures jumped 38%, to 7,929,000 from 5,731,000 cases. By

1994,

cataract surgery was the most common procedure with more than 2 million

operations, followed by cesarean section (858,000 procedures) and

inguinal

hernia operations (689,000 procedures). Knee arthroscopy procedures

increased 153% while prostate surgery declined 29%.(79)

The list of iatrogenic complications from surgery is as long as the list

of

procedures themselves. One study examined catheters that were inserted

to

deliver anesthetic into the epidural space around the spinal nerves for

lower cesarean section, abdominal surgery, or prostate surgery. In some

cases, non-sterile technique during catheter insertion resulted in

serious

infections, even leading to limb paralysis.(80)

In one review of the literature, the authors found " a significant rate

of

overutilization of coronary angiography, coronary artery surgery,

cardiac

pacemaker insertion, upper gastrointestinal endoscopies, carotid

endarterectomies, back surgery, and pain-relieving procedures. " (81)

A 1987 JAMA study found the following significant levels of

inappropriate

surgery: 17% of coronary angiography procedures, 32% of carotid

endarterectomy procedures, and 17% of upper gastrointestinal tract

endoscopy

procedures.(82) Based on the Healthcare Cost and Utilization Project

(HCUP)

statistics provided by the government for 2001, 697,675 upper

gastrointestinal endoscopies (usually entailing biopsy) were performed,

as

were 142,401 endarterectomies and 719,949 coronary angiographies.(13)

Extrapolating the JAMA study's inappropriate surgery rates to 2001

produces

118,604 unnecessary endoscopy procedures, 45,568 unnecessary

endarterectomies, and 122,391 unnecessary coronary angiographies. These

are

all forms of medical iatrogenesis.

MEDICAL AND SURGICAL PROCEDURES

It is instructive to know the mortality rates associated with various

medical and surgical procedures. Although we must sign release forms

when we

undergo any procedure, many of us are in denial about the true risks

involved; because medical and surgical procedures are so commonplace,

they

often are seen as both necessary and safe. Unfortunately, allopathic

medicine itself is a leading cause of death, as well as the most

expensive

way to die.

Perhaps the words " health care " confer the illusion that medicine is

about

health. Allopathic medicine is not a purveyor of health care but of

disease

care. The HCUP figures are instructive,(13) but the computer program

that

calculates annual mortality statistics for all US hospital discharges is

only as good as the codes entered into the system. In email

correspondence,

HCUP indicated that the mortality rates for each procedure indicated

only

that someone undergoing that procedure died either from the procedure or

from some other cause.

Thus there is no way of knowing exactly how many people die from a

particular procedure. While codes for " poisoning & toxic effects of

drugs "

and " complications of treatment " do exist, the mortality figures

registered

in these categories are very low and do not correlate with what is known

from research such as the 1998 JAMA study(1) that estimated an average

of

106,000 prescription medication deaths per year. No codes exist for

adverse

drug side effects, surgical mishaps, or other types of medical error.

Until

such codes exist, the true mortality rates tied to of medical error will

remain buried in the general statistics.

AN HONEST LOOK AT US HEALTH CARE

In 1978, the US Office of Technology Assessment (OTA) reported: " Only

10-20%

of all procedures currently used in medical practice have been shown to

be

efficacious by controlled trial. " (83) In 1995, the OTA compared medical

technology in eight countries ( Australia , Canada, France, Germany, the

Netherlands, Sweden, the UK, and the US ) and again noted that few

medical

procedures in the US have been subjected to clinical trial. It also

reported

that US infant mortality was high and life expectancy low compared to

other

developed countries.(84)

Although almost 10 years old, much of what was written in the OTA report

holds true today. The report blames the high cost of American medicine

on

the medical free-enterprise system and failure to create a national

health

care policy. It attributes the government's failure to control health

care

costs to market incentives and profit motives inherent in the current

financing and organization of health care, which includes such interests

as

private health insurers, hospital systems, physicians, and the drug and

medical-device industries. " Health Care Technology and Its Assessment in

Eight Countries " is the last report prepared by the OTA, which was

disbanded

in 1995. It also is perhaps the US government's last honest, detailed

examination of the nation's health care system. An appendix summarizing

this

60-page report follows this article.

SURGICAL ERRORS FINALLY REPORTED

An October 2003 JAMA study from the US government's Agency for

Healthcare

Research and Quality (AHRQ) documented 32,000 mostly surgery-related

deaths

costing $9 billion and accounting for 2.4 million extra hospital days in

2000.(85) Data from 20% of the nation's hospitals were analyzed for 18

different surgical complications, including postoperative infections,

foreign objects left in wounds, surgical wounds reopening, and

post-operative bleeding.

In a press release accompanying the study, AHRQ director Carolyn M.

Clancy,

MD, noted: " This study gives us the first direct evidence that medical

injuries pose a real threat to the American public and increase the

costs of

health care. " (86) According to the study's authors, " The findings

greatly

underestimate the problem, since many other complications happen that

are

not listed in hospital administrative data. " They added: " The message

here

is that medical injuries can have a devastating impact on the health

care

system. We need more research to identify why these injuries occur and

find

ways to prevent them from happening. " The study authors said that

improved

medical practices, including an emphasis on better hand washing, might

help

reduce morbidity and mortality rates. In an accompanying JAMA editorial,

health-risk researcher Dr. Saul Weingart of Harvard's Beth

Israel-Deaconess

Medical Center wrote, " Given their staggering magnitude, these estimates

are

clearly sobering. " (87)

UNNECESSARY X-RAYS

When x-rays were discovered, no one knew the long-term effects of

ionizing

radiation. In the 1950s, monthly fluoroscopic exams at the doctor's

office

were routine, and you could even walk into most shoe stores and see

x-rays

of your foot bones. We still do not know the ultimate outcome of our

initial

fascination with x-rays.

In those days, it was common practice to x-ray pregnant women to measure

their pelvises and make a diagnosis of twins. Finally, a study of

700,000

children born between 1947 and 1964 in 37 major maternity hospitals

compared

the children of mothers who had received pelvic x-rays during pregnancy

to

those of mothers who did not. It found that cancer mortality was 40%

higher

among children whose mothers had been x-rayed.(88)

In present-day medicine, coronary angiography is an invasive surgical

procedure that involves snaking a tube through a blood vessel in the

groin

up to the heart. To obtain useful information, X-rays are taken almost

continuously, with minimum dosages ranging from 460 to 1,580 mrem. The

minimum radiation from a routine chest x-ray is 2 mrem. X-ray radiation

accumulates in the body, and ionizing radiation used in X-ray procedures

has

been shown to cause gene mutation. The health impact of this high level

of

radiation is unknown, and often obscured in statistical jargon such as,

" The

risk for lifetime fatal cancer due to radiation exposure is estimated to

be

4 in one million per 1,000 mrem. " (89)

Dr. 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.

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. 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. e

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:

1. Thousands of prophylactic mastectomies are performed annually.

2. One-third of US women have had a hysterectomy before menopause.

3. Women are prescribed drugs more frequently than are men.

4. Women are given potent drugs for disease prevention, which results in

disease substitution due to side effects.

5. 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)

6. Normal processes such as menopause and childbirth have been heavily

" medicalized. "

7. 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:

1. 116 million extra physician visits

2. 77 million extra prescriptions filled

3. 17 million emergency department visits

4. 8 million hospitalizations

5. 3 million long-term admissions

6. 199,000 additional deaths

7. $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 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. 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

, 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:

1. X-ray exposures (mammography, fluoroscopy, CT scans).

2. Overuse of antibiotics for all conditions.

3. Carcinogenic drugs (hormone replacement therapy,* immunosuppressive

and prescription drugs).

4. Cancer chemotherapy(70)

5. Surgery and unnecessary surgery (cesarean section, radical

mastectomy,

preventive mastectomy, radical hysterectomy, prostatectomy,

cholecystectomies, cosmetic surgery, arthroscopy, etc.).

6. Discredited medical procedures and therapies.

7. Unproven medical therapies.

8. Outpatient surgery.

9. 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. Beral, director of the Cancer Research UK

Epidemiology

Unit: " We estimate that over the past decade, use of HRT by UK women

aged

50-64 has resulted in an extra 20,000 breast cancers,

estrogen-progestagen

(combination) therapy accounting for 15,000 of these. " (151) We were

unable

to find statistics on breast cancer, stroke, uterine cancer, or heart

disease caused by HRT used by American women. Because the US population

is

roughly six times that of the UK, it is possible that 120,000 cases of

breast cancer have been caused by HRT in the past decade.

OFFICE OF TECHNOLOGY ASSESSMENT (OTA)

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

General Facts

1. In 1990, US life expectancy was 71.8 years for men and 78.8 years for

women, among the lowest rates in the developed countries.

2. The 1990 US infant mortality rate in the US was 9.2 per 1,000 live

births, in the bottom half of the distribution among all developed

countries

3. Health status is correlated with socioeconomic status.

4. Health care is not universal.

5. Health care is based on the free market system with no fixed budget

or

limitations on expansion.

6. Health care accounts for 14% of the US GNP ($800 billion in 1993).

7. The federal government does no central planning, though it is the

major purchaser of health care for older people and some poor people.

8. Americans are less satisfied with their health care system than

people

in other developed countries.

9. US medicine specializes in expensive medical technology; some large

US

cities have more magnetic resonance image (MRI) scanners than most

countries

10. Huge public and private investments in medical research and

pharmaceutical development drive this " technological arms race. "

11. Any efforts to restrain technological developments in health care

are

opposed by policymakers concerned about negative impacts on

medical-technology industries.

Hospitals

1. In 1990, the US had 5,480 acute-care hospitals, 880 specialty

(psychiatric, long-term care, and rehabilitation) hospitals, and 340

federal

(military, veterans, and Native American) hospitals, or 2.7 hospitals

per

100,000 population.

2. In 1990, the average length of stay for 33 million admissions was 9.2

days. The bed occupancy rate was 66%. Lengths of stay were shorter and

admission rates lower than other countries.

3. In 1990, the US had 615,000 physicians, or 2.4 per 1,000 population;

33% were primary care (family medicine, internal medicine, and

pediatrics)

and 67% were specialists.

4. In 1991, government-run health care spending totaled $81 billion.

5. Total US health care spending rose to $752 billion in 1991 from $70

billion in 1950. Spending grew five-fold per capita.

6. Reasons for increased healthcare spending include:

1. The high cost of defensive medicine, with an escalation in

services solely to avoid malpractice litigation.

2. 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.

3. 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.

7. The reasons government attempts to control health care costs have

failed include:

1. 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.

2. Expansion is the goal of free enterprise.

Health-Related Research and Development

1. The US spends more than any other country on health-related R & D.

2. In 1989, the federal government spent $9.2 billion on R & D, while

private industry spent an additional $9.4 billion.

3. Total US R & D expenditures rose 50% from 1983 to 1992.

4. NIH receives about half of US government R & D funding.

5. NIH spent more on basic research ($4.1 billion in 1989) than for

clinical trials of medical treatments on humans ($519 million in 1989).

6. Most of the clinical trials evaluate new treatment protocols for

cancer and complications of AIDS, and do not study existing treatments,

even

though their effectiveness is in many cases unknown and questionable.

7. In 1990, the NIH had just begun to do meta-analysis and

cost-effectiveness analysis.

Pharmaceutical and Medical-Device Industries

1. About two-thirds of the industry's $9.4 billion budget went to drug

research; device manufacturers spent the remaining one-third.

2. In addition to R & D, the medical industry spent 24% of total sales on

promoting their products and 15% of total sales on development.

3. Total marketing expenses in 1990 were over $5 billion.

4. Many products provide no benefit over existing products.

5. Public and private health care consumers buy these products.

6. If health care spending is perceived as a problem, a highly

profitable

drug industry exacerbates the problem.

Controlling Health Care Technology

1. The FDA ensures the safety and efficacy of drugs, biologics, and

medical devices.

2. The FDA does not consider costs of therapy.

3. The FDA does not consider the effectiveness of a therapy.

4. The FDA does not compare a product to currently marketed products

5. The FDA does not consider nondrug alternatives for a given clinical

problem.

6. It costs $200 million in development costs to bring a new drug to

market. AIDS-drug interest groups forced new regulations that speed up

the

approval process.

7. Such drugs should be subject to greater post-marketing surveillance

requirements. As of 1995, these provisions had not yet come into play.

8. Many argue that reductions in the pre-approval testing of drugs open

the possibility of significant undiscovered toxicities.

Health Care Technology Assessment

1. Failure to evaluate technology was a focus of a 1978 report from OTA

with examples of many common medical practices supported by limited

published data (10-20%).

2. In 1978, Congress created the National Center for Health Care

Technology (NCHCT) to advise Medicare and Medicaid.

3. With an annual budget of $4 million, NCHCT published three broad

assessments of high-priority technologies and made about 75 coverage

recommendations to Medicare.

4. Congress disbanded NCHCT in 1981. The medical profession opposed it

from the beginning. The AMA testified before Congress in 1981 that

" clinical

policy analysis and judgments are better made-and are being responsibly

made-within the medical profession. Assessing risks and costs, as well

as

benefits, has been central to the exercise of good medical judgment for

decades. "

5. The medical device lobby also opposed government oversight by NCHCT.

Examples of Lack of Proper Management of HealthCare

Treatments for Coronary Artery Disease

1. Since the early 1970s, the number of coronary artery bypass surgeries

(CABGS) has risen rapidly without government regulation or clinical

trials.

2. Angioplasty for single vessel disease was introduced in 1978. The

first published trial of angioplasty versus medical treatment was done

in

1992.

3. Angioplasty did not reduce the number of CABGS, as was promoted.

4. Both procedures increase in number every year as the patient

population grows older and sicker.

5. Rates of use are higher in white patients and private insurance

patients, and vary greatly by geographic region, suggesting that use of

these procedures is based on non-clinical factors.

6. As of 1995, the NIH consensus program had not assessed CABGS since

1980 and had never assessed angioplasty.

7. RAND researchers evaluated CABGS in New York in 1990. They reviewed 1

300 procedures and found 2% were inappropriate, 90% were appropriate,

and 7%

were uncertain. For 1,300 angioplasties, 4% were inappropriate and 38%

uncertain. Using RAND methodologies, a panel of British physicians rated

twice as many procedures " inappropriate " as did a US panel rating the

same

clinical cases. The New York numbers are in question because New York

State

limits the number of surgery centers, and the per-capita supply of

cardiac

surgeons in New York is about one-half of the national average.

8. The estimated five-year cost is $33,000 for angioplasty and $40,000

for CABGS. Angioplasty did not lower costs, due to its high failure

rates.

Computed Tomography (CT)

1. The first CT scanner in the US was installed at the Mayo Clinic in

1973. By 1992, the number of operational CT scanners in the US had grown

to

6,060. By comparison, in 1993 there were 216 CT units in Canada .

2. There is little information available on how CT scans improve or

affect patient outcomes

3. In some institutions, up to 90% of scans performed were negative.

4. Approval by the FDA was not required for CT scanners, nor was any

evidence of safety or efficacy.

Magnetic Resonance Imaging (MRI)

1. MRIs were introduced in Great Britain in 1978 and in the US in 1980.

By 1988, there were 1,230 units and by 1992 between 2,800 and 3,000.

2. A definitive review published in 1994 found less than 30 studies of 5

000 that were prospective comparisons of diagnostic accuracy or

therapeutic

choice.

3. The American College of Physicians assessed MRI studies and rated 13

of 17 trials as " weak, " i.e., lacking data concerning therapeutic impact

or

patient outcomes.

4. The OTA concluded: " It is evident that hospitals,

physician-entrepreneurs, and medical device manufacturers have

approached

MRI and CT as commodities with high-profit potential, and

decision-making on

the acquisition and use of these procedures has been highly influenced

by

this approach. Clinical evaluation, appropriate patient selection, and

matching supply to legitimate demand might be viewed as secondary

forces. "

Laparoscopic Surgery

1. Laparoscopic cholecystectomy was introduced at a professional

surgical

society meeting in late 1989. By 1992, 85% of all cholecystectomies were

performed laparoscopically.

2. There was an associated increase of 30% in the number of

cholecystectomies performed.

3. Because of the increased volume of gall bladder operations, their

total cost increased 11.4% between 1988 and 1992, despite a 25.1% drop

in

the average cost per surgery.

4. The mortality rate for gall bladder surgeries did not decline as a

result of the lower risk because so many more were performed.

5. When studies were finally done on completed cases, the results showed

that laparoscopic cholecystectomy was associated with reduced inpatient

duration, decreased pain, and a shorter period of restricted activity.

But

rates of bile duct and major vessel injury increased and it was

suggested

that these rates were worse for people with acute cholecystitis. No

clinical

trials had been done to clarify this issue.

6. Patient demand, fueled by substantial media attention, was a major

force in promoting rapid adoption of these procedures.

7. The major manufacturer of laparoscopic equipment produced the video

that introduced the procedure in 1989.

8. Doctors were given two-day training seminars before performing the

surgery on patients.

Infant Mortality

1. In 1990, the US ranked 24th in infant mortality of 38 developed

countries with a rate of 9.2 deaths per 1,000 live births.

2. US black infant mortality is 18.6 per 1,000 live births, compared to

8

8 for whites.

Screening for Breast Cancer

1. Mammography screening in women under 50 has always been a subject of

debate.

2. In 1992, the Canadian National Breast Cancer Study of 50,000 women

showed that mammography had no effect on mortality for women aged 40-50.

3. The National Cancer Institute (NCI) refused to change its

recommendations on mammography.

4. The American Cancer Society decided to wait for more studies on

mammography.

5. In December 1993, NCI announced that women over 50 should have

routine

screenings every one to two years but that younger women would derive no

benefit from mammography.

Summary

1. The OTA concluded: " There are no mechanisms in place to limit

dissemination of technologies regardless of their clinical value. "

Shortly after the release of this report, the OTA was disbanded.

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