By Barry M. Charles, MD
An Overview Based on a Selection of Findings from the More than 10,000 Articles, Reports, and Scientific Research Studies in the Medical Literature
´We should 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 recognised as a health hazard of global proportions. MEDLINE (the computerised 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 ´iatroepidemic2´. 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 days3´. 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 accidents combined4´.
An Economic Drain
Medication-caused 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 disease5. 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.
Hazardous Hospital Environment
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 medication6.
The results of an analysis of cardiac arrests at a teaching hospital found that 64 per cent were preventable. Inappropriate use of drugs was the leading cause7.
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 side effects8. Every medication, 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 drug effects, Dr. David Kessler, Chief of the U.S. Food and Drug Administration, believes that ´only one per cent of all serious drug reactions are reported9´.
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 cancers10´. 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 control11. 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 malignancies12. 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.
Unnecessary Surgery Epidemic
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 billion13.
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 malfunction14.
Unreliable Medical Care
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 effective15. 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 it16.
Pushing Poisonous Drugs
Pharmaceutical marketing also puts great pressure on physicians to use new products. The medical journal Hospital 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 Great Britain. Zomepirac sodium was also ´aggressively marketed as a safe analgesic´, but withdrawn after a year and numerous reports of fatal anaphylaxis17. 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 placebo.
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 proliferate18´. In addition to side effects, the high cost of pharmaceuticals are a significant hazard to the economy of developing countries.
Urgent 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 fallibility19´. 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.
USA Today. September 13, 1995.
Review of Respiratory Diseases. 1987; 135: 1152-1156.
Journal of the American Medical Association. 1994; 272: 1851-1857.
Journal of the American Medical Association. 1995; 274: 29-34.
Archives of Internal Medicine. 1995; 155: 1949-1956.
Annals of Internal Medicine. 1964; 60: 100-110. New England Journal of Medicine. 1981; 304: 638-642. New England Journal of Medicine. 1991; 324: 370-376.
Journal of the American Medical Association. 1991; 265: 2815-2820.
Harrison´s Principles of Internal Medicine. 1994.
US News and World Report. January 9, 1995: 49-54.
New England Journal of Medicine. 1994; 330: 1062-1071.
American Journal of Medicine. 1995; 99: 48-54.
New England Journal of Medicine. 1990; 322: 1-6
USA Today. October 31, 1983.
Nursing Clinics of North America. 1993; 28: 459-473.
British Medical Journal. 1991; 303: 798-799.
New England Journal of Medicine. 1989; 321: 1281-1284.
Hospital Practice. 1989; January 30: 89-94.
Journal of Clinical Epidemiology. 1991; 44: 49S-55S.
Journal of the American Medical Association. 1989; 261: 1610-1617.