Table 1: Estimated Annual Mortality and Economic Cost of Medical Intervention

Using Leape's 1997 medical and drug error rate of 3 million(14) multiplied by the 14% fatality rate he used in

1994(16) produces an annual death rate of 420,000 for drug errors and medical errors combined. Using this number instead of Lazorou's 106,000 drug errors and the Institute of Medicine 's (IOM) estimated 98,000 annual medical errors would add another 216,000 deaths, for a total of 999,936 deaths annually.

Table 2: Estimated Annual Mortality and Economic Cost of Medical Intervention

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)

In16.4 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.

Table 3: Estimated 10-Year Death Rates from Medical Intervention

Our estimated 10-year total of 7.8 million iatrogenic deaths is more than all the casualties from all the wars fought by the US throughout its entire history.

Our projected figures for unnecessary medical events occurring over a 10-year period also are dramatic.

Table 4: Estimated 10-Year Unnecessary Medical Events

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; (b) insufficient exercise; (c) 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. 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)

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.

Cynthia 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, even from ourselves.”(30) It may be hard to accept, but it is not difficult to understand why only 1 in 20 side effects is reported to either hospital administrators or the FDA. (31, 31a)

If hospitals admitted to the actual number of errors for which they are responsible, which is about 20 times what is reported, they would come under intense scrutiny.(32) Jerry Phillips, associate director of the FDA's Office of Post Marketing Drug Risk Assessment, confirms this number. “In the broader area of adverse drug reaction data, the

250,000 reports received annually probably represent only 5% of the actual reactions that occur.”(33) Dr. Jay Cohen, who has extensively researched adverse drug reactions, notes that because only 5% of adverse drug reactions are reported, there are in fact 5 million medication reactions each year.(34)

A 2003 survey is all the more distressing because there seems to be no improvement in error reporting, even with all the attention given to this topic. Dr. Dorothea Wild surveyed medical residents at a community hospital in Connecticut and found that only half were aware that the hospital had a medical error-reporting system, and that the vast majority did not 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. Wild adds that error reporting is the first step in locating the gaps in the medical system and fixing them. Not even that first step has been taken to date.(35)

PUBLIC SUGGESTIONS ON IATROGENESIS

In a telephone survey, 1,207 adults ranked the effectiveness of the following measures in reducing preventable medical errors that result in serious harm.(36) (Following each measure is the percentage of respondents who ranked the measure as “very effective.”)

giving doctors more time to spend with patients (78%)

requiring hospitals to develop systems to avoid medical errors (74%)

better training of health professionals (73%)

using only doctors specially trained in intensive care medicine on intensive care units (73%)

requiring hospitals to report all serious medical errors to a state agency (71%)

increasing the number of hospital nurses (69%)

reducing the work hours of doctors in training to avoid fatigue (66%)

encouraging hospitals to voluntarily report serious medical errors to a state agency (62%).

DRUG IATROGENESIS

Prescription drugs constitute 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 study(1) showed. 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% of patients admitted to these hospitals each year. The authors concluded that at least 90,895 patients annually were harmed by medication errors in the US as a whole.(37)

A 2002 study shows that 20% of hospital medications for patients had dosage errors. Nearly 40% of these errors were considered potentially harmful to the patient. In a typical 300-patient hospital, the number of errors per day was

40.(38)

Problems involving patients' medications were even higher the following year. The error rate intercepted by pharmacists in this study was 24%, 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 setting (requiring highly specialized skills, technology, or support services). Seventy-six patients (19%) had adverse events. Adverse drug events were the most common, at 66% of all events. The next most common event was procedure-related injuries, at 17%.(40)

In a New England Journal of Medicine 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, "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 New England Journal 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 selective serotonin reuptake inhibitors ( SSRIs), nonsteroidal anti-inflammatory drugs (NSAIDs), and calcium-channel blockers. Reuters also

reported that prior research has suggested that nearly 5% 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 that one of the reasons for this failure is that in nearly two-thirds of the cases, doctors could not diagnose drug side effects or the side effects persisted because the doctor failed to heed the warning signs.

Medicating Our Feelings

Patients seeking a more joyful existence and relief from worry, stress, and anxiety often fall victim to the messages endlessly displayed on TV and billboards. Often, instead of gaining relief, they fall victim to the myriad iatrogenic side effects of antidepressant medication.

Moreover, a whole generation of antidepressant users has been created 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 rather than with their inner resources. As adults, these medicated youth reach for alcohol, drugs, or even street drugs to cope. According to JAMA , “Ritalin acts much like cocaine.”(43) Today's marketing of mood-modifying drugs such as Prozac and Zoloft ® makes them not only socially acceptable but almost a necessity in today's stressful world.

Television Diagnosis

To reach the widest audience possible, drug companies are no longer just targeting medical doctors with their marketing of antidepressants. By 1995, drug companies had tripled the amount of money allotted to direct advertising of prescription drugs to consumers. The majority of this money is spent on seductive television ads. From 1996 to

2000, spending rose from $791 million to nearly $2.5 billion.(44) This $2.5 billion represents only 15% of the total pharmaceutical advertising budget. While the drug companies maintain that direct-to-consumer advertising is educational, Dr. Sidney M. Wolfe of the Public Citizen Health Research Group in Washington, DC, argues that the

Specific Drug Iatrogenesis: Antibiotics

According to William Agger, MD, director of microbiology and chief of infectious disease at Gundersen Lutheran

Medical Center in La Crosse, WI, 30 million pounds of antibiotics are used in America each year.(50) Of this amount,

25 million pounds are used in animal husbandry, and 23 million pounds are used to try to prevent disease and the stress of shipping, as well as to promote growth. Only 2 million pounds are given for specific animal infections. Dr. Agger reminds us that low concentrations of antibiotics are measurable in many of our foods and in various waterways around the world, much of it seeping in from animal farms.

Agger contends that overuse of antibiotics results in food-borne infections resistant to antibiotics. Salmonella is found in 20% of ground meat, but the constant exposure of cattle to antibiotics has made 84% of salmonella resistant to at least one anti-salmonella antibiotic. Diseased animal food accounts for 80% of salmonellosis in humans, or 1.4 million cases per year. The conventional approach to countering this epidemic is to radiate food to try to kill all organisms while continuing to use the antibiotics that created the problem in the first place. Approximately 20% of chickens are contaminated with Campylobacter jejuni, an organism that causes 2.4 million cases of illness annually. Fifty-four percent of these organisms are resistant to at least one anti-campylobacter antimicrobial agent.

Denmark banned growth-promoting antibiotics beginning in 1999, which cut their use by more than half within a year, from 453,200 to 195,800 pounds. A report from Scandinavia found that removing antibiotic growth promoters had no or minimal effect on food production costs. Agger warns that the current crowded, unsanitary methods of animal farming in the US support constant stress and infection, and are geared toward high antibiotic use.

In the US, 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. Agger 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 U.S. still receive antibiotics from their doctor.(51)

According to the CDC, 90% of upper respiratory infections are viral and should not be treated with antibiotics. In

Germany, the prevalence of systemic antibiotic use in children aged 0-6 years was 42.9%.(52)

Data obtained from nine US health insurers on antibiotic use in 25,000 children from 1996 to 2000 found that rates of antibiotic use decreased. Antibiotic use in children aged three months to under 3 years decreased 24%, from 2.46 to

1.89 antibiotic prescriptions per patient per year. For children aged 3 to under 6 years, there was a 25% 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% reduction from 0.85 to 0.69 antibiotic prescriptions per patient per year.(53) Despite these reductions, 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, with penicillin and erythromycin the only recommended treatment. Ninety percent of sore-throat cases, however, are viral. Antibiotics were used in 73% of the estimated 6.7 million adult annual visits for sore throat in the US between 1989 and 1999. Furthermore, patients treated with antibiotics were prescribed non-recommended broad-spectrum antibiotics in 68% of visits. This period saw a significant increase in the use of newer, more expensive broad-spectrum antibiotics and a decrease in use of the recommended antibiotics penicillin and erythromycin.(54) Antibiotics being prescribed in 73%

of sore-throat cases instead of the recommended 10% resulted in a total of 4.2 million unnecessary antibiotic prescriptions from 1989 to 1999.

The Problem with Antibiotics

In September 2003, the CDC re-launched a program started in 1995 called “Get Smart: Know When Antibiotics Work.”(55) This $1.6 million campaign is designed to educate patients about the overuse and inappropriate use of antibiotics. Most people involved with alternative medicine have known about the dangers of antibiotic overuse for decades. Finally the government is focusing on the problem, yet it is spending only a miniscule amount of money on an iatrogenic epidemic that is costing billions of dollars and thousands of lives. The CDC warns that 90% of upper

respiratory infections, including children's ear infections, are viral and that antibiotics do not treat viral infection. More than 40% of about 50 million prescriptions for antibiotics written each year in physicians' offices are inappropriate.(2) 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) The CDC, however, seems to be blaming patients for misusing antibiotics even though they are available only by prescription from physicians. According to Dr. Richard Besser, head of “Get Smart”: "Programs that have just targeted physicians have not worked. Direct-to- consumer advertising of drugs is to blame in some cases.” 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)