Overview Based on a Selection of Findings from the More than
and Scientific Research Studies in the Medical Literature
By Barry M. Charles, MD
make people aware to the uncertainties of medicine. Not
everybody will be cured and in some cases disasters will occur.
That's reality. Medical practice, by necessity, always will be
based on trail and error.' - -
The American Medical Association's Roy Schwarz, MD Group
Vice-President of Scientific Education and Practice Standards
Iatrogenic illness --
disease produced as a result of medical treatment -- is now
recognized as a health hazard of global proportions. MEDLINE
(the computerized medical research database of the United States
National Library of Medicine) includes over 7,000 articles,
reports, and scientific research papers since 1966 that show a
substantial number of patients suffer treatment-caused disorders
and adverse drug reactions. These harmful effects, which can be
serious and even lethal, are associated with every facet of
modern medicine including drugs, other medical therapies,
diagnostic procedures, and surgery.
Massive Detrimental Effects
- Detrimental effects
have become so extensive as to prompt the use of the term 'iatro-epidemic'.
Reporting in the Journal of the American Medical Association,
Dr. Lucien Leape of Harvard School of Public Health, has
calculated that '180,000 people die in the U.S. each year partly
as a result of iatrogenic injury, the equivalent of
three jumbo-jet crashes every two
days'. In another issue, the Journal of the American
Medical Association points out that injury from medical
treatment in the U.S. 'dwarfs the annual automobile accident
mortality of 45,000 and accounts for
more deaths than all other
An Economic Drain
disorders produce a substantial economic drain. For example, the
Archives of Internal Medicine reported a cost to the U.S.
economy of $76 billion in 1995. This amount is nearly twice that
spent on diabetes treatment and near the amount for
cardiovascular disease. Iatrogenic disease can be due to many
factors. These include: errors in prescribing or administering
drugs and other treatments; accidents; inappropriate use of
diagnostic or therapeutic measures; and the intrinsic potential
for harm and side effects associated with medications, surgery,
and other procedures.
The hospital environment is
especially conducive to medical hazards. Studies including those
conducted at Harvard Medical School show that as many as 36 per
cent of patients admitted to hospitals suffered iatrogenic
injury with up to 25 per cent of those being serious or fatal.
Up to half of these injuries were related to the use of
medication. The results of an analysis of
cardiac arrests at a
teaching hospital found that 64 per
Inappropriate use of drugs was the leading cause. In addition to
treatment-caused disorders, hospitals foster life-threatening
nosocomial infections involving rare or drug-resistant
micro-organisms, which are often difficult to treat. Fifteen
per cent of hospital days are devoted to the treatment of drug
including those that are sold over the counter without a
prescription, has an associated side effect.
Commonly used drugs have been found to affect every system.
Frequent reactions include skin rashes, nausea, headaches,
dizziness, lethargy, diarrhoea, and gastric bleeding in a
significant number of people. More severe reactions that can be
fatal or severely debilitating include deafness, depression,
abnormal heart rhythms, angina, bronchospasm, electrolyte
disturbances, immune system dysfunction, serious blood disorders
such as aplastic anaemia, liver or kidney toxicity,
Stevens-Johnson syndrome, or anaphylactic shock. These occur in
a statistically significant proportion of the population.
Despite what is known about adverse
effects, Dr. David Kessler, former Chief of the U.S. Food and
Drug Administration, believes that 'only one per cent of all
serious drug reactions are reported'.
Public Health in Jeopardy
- The problem escalates
to public health proportions when large numbers receive a
treatment and experience its attendant side effect. The New
England Journal of Medicine makes this point in discussing
the link between breast cancer and menopausal hormone
replacement therapy: 'because of the high incidence of breast
cancer even a slight increase in risk will yield a substantial
increase in the number of cancers'.
The scale of use causes drugs which are considered safe to end
up producing significant damage. In this regard, the widely used
non-steroidal anti-inflammatory drugs cause over 3,300 deaths
per year and 41,000 hospitalisations.
- Many drugs have side
effects serious enough to cause a secondary disease warranting
its own intensive therapy. An example is Parkinsonism
caused by the neurological side
effects of anti-depressants or anti-psychotic medication.
A Harvard Medical School study showed that
drugs were the real cause of the
original symptoms in 37 per cent of elderly patients who were
treated for Parkinson's disease. L-dopa, the medication
used in treating these patients has its own severe side effects,
that often require the use of additional drugs to control. Other
examples of new diseases caused by medications include collagen
vascular disease produced by blood pressure medications, and
Cushing's syndrome produced by prolonged cortico-steroid use.
The New England Journal of Medicine has published several
studies linking cancer chemotherapy to the later appearance of
new malignancies. Many drugs are classified as teratogens and
cause birth defects when taken during pregnancy. Others can
cause diseases in offspring in later life. Unfortunately, these
effects may not become apparent until many thousands of women
have taken a drug which had been enthusiastically introduced and
promoted, the classic example being the tragic epidemic of birth
defects in Europe due to thalidomide, or cancer in the children
of mothers who took diethylstilbestrol. Overuse of antibiotics
has produced resistant strains of formerly susceptible
micro-organisms. Serious concern has been voiced about the
potential for epidemics which cannot be effectively contained
due to drug resistance. An example of this is the emergence of
tuberculosis that is resistant to presently available drugs.
- Studies also show
substantial inappropriate and overuse of surgery, and continued
use of outmoded operations. A U.S. Congress Subcommittee on
Oversight and Investigations into Unnecessary Surgery found that
in one year, there were approximately
two million unnecessary operations, responsible for more than
12,000 deaths, with an approximate cost wastage of $10
- Dependency on high
technology both in diagnosis and treatment has been shown to be
a source of injury with machine failure or misapplication of
technology. For example, 36 per cent of iatrogenic problems in
intensive care units were associated with equipment malfunction.
- In addition, medical
care is often based on much less scientific evidence than
assumed and undergoes radical reversals. The editor of the
British Medical Journal revealed that
only 15 per cent of all medical
therapies have a scientific basis or have been demonstrated to
be effective. Yet patients remain vulnerable. An example
is the formerly common use of irradiation for enlargement of the
thymus in infancy, a condition now recognised to be normal. This
treatment has recently been shown to cause cancer in later life
in those who received it.
marketing also puts great pressure on physicians to use new
products. The medical journal
Practice pointed out
that pharmaceutical company competition 'leads to very
aggressive promotion and inundation of the physician with data
supporting the use of each new drug'. Such marketing may dilute
opposing scientific information that is not as well publicised.
Ultimately drugs may be withdrawn, but only after substantial
harm has been done. For example,
benoxaprofen, a non-steroidal anti-inflammatory agent (NSAID)
was introduced and heavily marketed in 1982, but then withdrawn
after cases of fatal liver toxicity were reported in
Zomepirac sodium was also 'aggressively marketed as a safe
analgesic', but withdrawn after a year and numerous reports of
fatal anaphylaxis. The cardiac drugs flecainide and encainide,
heavily promoted to control abnormal heart rhythms, were then
withdrawn years later after scientific studies showed they
caused fatal arrythmias and that those treated with them were
two-and-one-half times as likely to die as were those taking a
Developing countries, which have less stringent controls and
means of surveillance, have had special problems with irrational
drug marketing by multinational and indigenous pharmaceutical
companies that have been carefully documented. These practices
have been reviewed in the Journal
of Clinical Epidemiology
by several authors including Dr. Philip Lee, the United States
Assistant Secretary of Health. According to Dr. Lee and his
colleagues, 'unjustified claims of efficacy or safety continue
to proliferate'. In addition to side effects, the high cost of
pharmaceuticals are a significant hazard to the economy of
Need for New Knowledge
- Physicians and
patients have come to accept medical hazards as a necessary
price to pay for modern diagnosis and therapy even though they
may be seriously debilitating or lethal. The same is true with
medical errors. Studies have shown errors to be so pervasive
that mistakes are considered to be an inevitable part of the
medical system, giving rise to the term 'necessary fallibility'.
The deplorable acceptance of disease or medical error as a
consequence of treatment reflects a deviation from the most
primary principle of medical ethics -- primum non nocere --
'Above all do no harm.' The wealth of data documenting the
serious nature and extent of the hazards associated with modern
medicine has made clear that fundamental deficiencies exist in
the current medical approach and that new knowledge is urgently
needed to effectively address this problem.
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