Underreporting of Iatrogenic Events
As few as 5% and no more than 20% of iatrogenic events are ever reported.25,27-30 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.25 Our considerably higher figure is equivalent to six jumbo jets 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 (IRBs) to advise on clinical trial research also serve as consultants to the pharmaceutical industry.31 The study authors were concerned that such representation could cause potential conflicts of interest. In a news release, Dr. Erik Campbell, the lead author, wrote, “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.”32
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.”33
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 wrote that growing conflicts of interest are tainting science and called for stronger restrictions on pharmaceutical stock ownership and other financial incentives for researchers:34 “When the boundaries between industry and academic medicine become as blurred as they are now,” Angell wrote, “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.35 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, in 1996 published Tainted Truth: The Manipulation of Fact in America, a book about the widespread practice of lying with statistics.36 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 1981, the drug industry “gave” $292 million to colleges and universities for research. By 1991, 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).25 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 1991,37 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 US, 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.”27
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.24
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 1994.25 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.25 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.28 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.38 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 conservative figures.
An article in Psychiatric Times (April 2000) outlines the stakes involved in reporting medical errors.39 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 US 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.39 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.40
Standard medical pharmacology texts admit that relatively few doctors ever report adverse drug reactions to the FDA.41 The reasons range from not knowing such a reporting system exists to fear of being sued.42 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.”43 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.44
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.29 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.”30 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.45
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 do not 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.46