Never before have complete statistics on the multiple causes of iatrogenesis been combined in one book. 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 the pieces of the puzzle together.
US healthcare spending reached $1.6 trillion in 2003, representing 14% of the nation’s gross national product.118 When spending rose to $2.4 trillion per year in 2007, it would represent 17% of the gross domestic product.119 Considering this enormous expenditure, which occurred in 2008 as well, 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:
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, as evidenced by efforts to curtail use of effective vitamins and supplements. The recent article, “US Spends $700 Billion on Unnecessary Medical Tests,” which appears on the Healthcare Economist website, reflects the state of our techno-med nation:
Peter Orszag, director of the Congressional Budget Office, estimates that 5 percent of the nation’s gross domestic product—$700 billion per year—goes to tests and procedures that do not actually improve health outcomes. . . . The unreasonably high cost of healthcare in the United States is a deeply entrenched problem that must be attacked at its root.” This quotation comes from a Progressive Policy Institute (PPI) report. There is little doubt that much of healthcare is unnecessary or at least is not worthwhile in the cost-benefit sense.120
Moreover,
Some medical experts say the American devotion to the newest, most expensive technology is an important reason that the United States spends much more on healthcare than other industrialized nations. . . without providing better care. . . . [A] Rand Corporation study estimated that one-third or more of the care that patients in this country receive could be of little value. If that is so, hundreds of billions of dollars each year are being wasted on superfluous treatments.
[There is] a much larger trend in American medicine. . . . A faith in innovation, often driven by [quick] financial incentives, encourages American doctors and hospitals to adopt new technologies even without proof that they work better than older techniques. . . . The problem is not that newer treatments never work. It is that once they become available, [too often prematurely,] they are often used indiscriminately, in the absence of studies to determine which patients they will benefit. . . . And sometimes, the new technologies prove harmful. . . . [Some] doctors in private practice who own their [CT] scanners, use the tests aggressively . . . [as if it were] a new toy in the office121
—endangering asymptomatic patients for whom the scan may be inappropriate.
To determine whether American medicine is working, we also need to know if enough people have access to the American healthcare system. The National Coalition on Healthcare reports, “Nearly 46 million Americans, or 18 percent of the population under the age of 65, were without health insurance in 2007, the latest government data available.”122 As of September 2007, one out of three Americans were uninsured. 123, 124 This number is apt to rise sharply for 2008 and 2009 because so many Americans are losing their jobs in the recession.
The number of uninsured children in 2007 was 8.1 million—or 10.7 percent of all children in the US. . . . The large majority of the uninsured (80 percent) are native or naturalized citizens. . . . The number of uninsured rose 2.2 million between 2005 and 2006 and has increased by almost 8 million people since 2000. . . .
A study found that 29 percent of people who had health insurance were “underinsured” with coverage so meager they often postponed medical care because of costs. Nearly 50 percent overall, and 43 percent of people with health coverage, said they were “somewhat” to “completely” unprepared to cope with a costly medical emergency over the coming year.125
The National Coalition on Healthcare advises,
Getting everyone covered will save lives and money. The impacts of going uninsured are clear and severe. Many uninsured individuals postpone needed medical care which results in increased mortality and billions of dollars lost in productivity and increased expenses to the healthcare system.126
The Los Angeles Times almost waxes poetic about healthcare insurance as journalist Ricardo Alonso-Zaldivar observes, “Some people marry for love, some for companionship, and others for status or money. Now comes another reason to get hitched: health insurance.”127
A poll of 2,003 adults released on April 27, 2008 (on the cusp of our economic recession) by the Kaiser Family Foundation found that “7% of Americans said they or someone in their household decided to marry in the last year so they could get healthcare benefits via their spouse.” Not surprisingly, “Those who cited health insurance as a factor in deciding to marry tended to have modest incomes. About 6 in 10 were in households making less than $50,000 a year, said Mollyann Brodie, who directs Kaiser’s opinion research.” What surprised researchers was that such costs had become a factor in marriage decisions. “We should have asked about divorce,” said Drew E. Altman, president of the Kaiser Family Foundation, “joking.”128
The Institute of Medicine found that the 41 million Americans with no health insurance have consistently worse clinical outcomes than those who are insured, and are at increased risk for dying prematurely.129
Compounding the problem is the issue of insurance fraud. When doctors bill for services they do not render, advise unnecessary tests, or screen everyone for a rare condition, they are committing insurance fraud. The US GAO estimated that $12 billion was lost to fraudulent or unnecessary claims in 1998, and reclaimed $480 million in judgments in that year. In 2001, the federal government won or negotiated more than $1.7 billion in judgments, settlements, and administrative impositions in healthcare fraud cases and proceedings.130
As little as 5% and no more than 20% of iatrogenic events are ever reported.131–135 This implies that if medical errors were completely and accurately reported, we would have an annual iatrogenic death toll much higher than 794,936. 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.136 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.
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.137 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.”138 The public is mostly unaware of these interlocking interests. (For more on this, see chapter 8, “Medical Ethics and Conflict of Interest in Scientific Medicine.”)
Government medical advisors play a role in adequate reporting of iatrogenic events. The FDA announced in March 2007:
Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules . . . for the FDA’s powerful advisory committees. Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions. A “significant number” of the agency’s present advisers would be affected by the new policy, said the FDA acting deputy commissioner, Randall W. Lutter, though he would not say how many.139
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).140 He noted 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 1991,141 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.
At the same time, 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.”142
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.143
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 1994.144 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.
If the medical system were a bank, you wouldn’t deposit your money here, because there would be an error every one-in-two to one-in-three times you made a transaction.
Stephen Persell, MD, Northwestern University’s Feinberg School of Medicine145
In 1994, Leape said he was well aware that medical errors were not being reported.146 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.147
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.148
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.149 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 Accountability 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.150 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.151
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.152
In their article, “Underreporting of Medical Errors Affecting Children Is a Significant Problem, Particularly among Physicians,” the Agency for Healthcare Research and Quality (AHRQ) reports that a study in 2004 published in the journal Pediatrics discovered that most medical errors made by nurses and physicians treating children are never reported.153,154
On February 17, 2008, Indiana University School of Medicine aired a revealing radio interview with Lauris Kaldjian, MD, PhD, of the Dept. of Internal Medicine and Program in Biomedical Ethics at the University of Iowa’s Roy J. and Lucille A. Carver College of Medicine. The program was called, “Doctors Don’t Report Medical Errors.” A question is posed:
Let’s say you’re a doctor—a heart surgeon. And you make a mistake. Maybe you prescribe the wrong medicine. Maybe you cut something you’re not supposed to. And it might not be a big deal. But then again, it might. The question is: do you admit your mistake and report it to the higher ups?
Lauris Kaldjian directs the bioethics program at the University of Iowa. According to his recent study, the answer to that question is probably no. Most doctors he surveyed agree in theory that’s it’s a good thing to report medical errors. But few actually do it.155
Dr. Kaldjian’s report on medical errors appears in the January 14, 2008, issue of the Archives of Internal Medicine.
A five-country survey published in the Journal of Health Affairs found that 18–28% of people who were recently ill had suffered from a medical or drug error in the previous two years. The study surveyed 750 recently ill adults. The breakdown by country showed the percentages of those suffering a medical or drug error were 18% in Britain, 23% in Australia and in New Zealand, 25% in Canada, and 28% in the US.156
In a telephone survey, 1,207 adults ranked the effectiveness of the following measures in reducing preventable medical errors that result in serious harm.157 Following each measure is the percentage of respondents who ranked the measure as “very effective.”
Various initiatives are under way to address these problems. The Patient Safety and Quality Improvement Act of 2005158 “was enacted in response to growing concern about patient safety in the United States. . . . The goal of the Act is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.”159 The success of this legislation will depend in large part upon the willingness of healthcare providers to reveal errors of colleagues, as well as their own in a challenging medical environment that reveres the concept of accuracy.
A new specialty in modern medicine that is developing in part from the focus on the need for improved quality of hospital care is Hospital Medicine. It trains physicians as “hospitalists” to devote themselves to the safety of hospital patients. These would be the doctors referred to above who are “specially trained in intensive care medicine on intensive care units.” These would also be the physicians who are there to relieve doctors in training, which would allow doctors’ shifts to be reduced in order to combat fatigue and reduce errors. In 2009, The American Board of Hospital Medicine (ABHM), was founded as the first board of certification for Hospital Medicine in North America. The specialized training of “hospitalists” and the increase in their future numbers may enable them to spend more time with patients, which appears to be a priority with the public. There are also campaigns to increase the number of hospital nurses and to educate them regarding hospital errors.