Death by Medicine, Part I - Gary Null PhD

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[sSRI-Research] Death by Medicine, Part I - Gary Null PhD

 

 

 

 

Death by Medicine, Part I

http://mercola.com/2003/nov/26/death_by_medicine.htm

 

By Gary Null PhD, Carolyn Dean MD ND, Martin Feldman MD, Debora Rasio

MD, Dorothy Smith 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. Richard 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:

 

1.. In 16.4 million people, 2.1% chance of a serious adverse

drug reaction,1 (186,000)

 

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

nosocomial infection,9 (489,500)

 

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

iatrogenic injury in hospital (medical error and adverse drug

reactions),16 (1.78 million)

 

4.. 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; (b)

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. Erik Campbell, the lead author, said, " Our

previous research with faculty has shown us that ties to industry can

affect scientific behavior, leading to such things as trade secrecy

and delays in publishing research. It's possible that similar

relationships with companies could affect IRB members' activities and

attitudes. " 18

 

Medical Ethics and Conflict of Interest in Scientific Medicine

 

 

Jonathan Quick, director of Essential Drugs and Medicines Policy

for the World Health Organization (WHO) wrote in a recent WHO

Bulletin: " If clinical trials become a commercial venture in which

self-interest overrules public interest and desire overrules science,

then the social contract which allows research on human subjects in

return for medical advances is broken. " 19

 

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.

 

Cynthia 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 Phillips, 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

 

a.. giving doctors more time to spend with patients: very

effective 78 percent

b.. requiring hospitals to develop systems to avoid medical

errors: very effective 74 percent

c.. better training of health professionals: very effective 73

percent

d.. using only doctors specially trained in intensive care

medicine on intensive care units: very effective 73 percent

e.. requiring hospitals to report all serious medical errors

to a state agency: very effective 71 percent

f.. increasing the number of hospital nurses: very effective

69 percent

g.. reducing the work hours of doctors-in-training to avoid

fatigue: very effective 66 percent

h.. 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 William 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. Richard 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.