The Patient Safety Crusade--a Phony Crisis
The American health care system is the biggest business sector in the country. As a result, it is a very attractive target for ambitious politicians and policymakers, with more than $2 trillion a year in expenditures. If an ambitious group of politicians and meddlers would like to expand government, American health care is the logical target.
An effective strategy to seal the deal would be to accuse the health care system of killing people. That should undermine public confidence and soften people up for the idea that the government would do a better job.
Toward that end, in 1999 the Institute of Medicine (IOM), a government policy and science agency, part of the National Academy of Sciences, published a monograph titled To Err Is Human (1) and followed with an extensive public relations campaign accusing American hospital personnel of negligently killing as many as 100,000 people every year. This harsh and false criticism of the best hospitals, physicians, and nurses on the planet has been joined by other government-funded entities and professors at supposedly independent universities, including many medical academics.
There is no crisis of patient safety in American hospitals, no epidemic of medical incompetence. As a longtime medical negligence analyst, I was outraged to read the 1999 IOM news release and public relations campaign. I had previously analyzed the 1979 California and 1991 Harvard reports that the IOM was relying on and found them both to show no such crisis.
The IOM campaign actually commenced before formal publication of the Harvard 1992 study. All the studies in three separate decades showed no crisis, the same rate of incidents, so there was clearly no epidemic. The rates of negligent injury were very low for such a complicated human activity, less than a quarter of a percent consistently in all the studies. Nonetheless, all the experts were declaring a catastrophe.
Voices of Reason
Fortunately, the patient safety crusade and the IOM failed to anticipate the opposition of a nationally prominent patient safety expert, an honest Harvard physician and attorney named Troyen Brennan.
Troyen Brennan M.D., J.D. was the lead Harvard researcher on the two studies that were used as the backbone of the IOM report. Dr. Brennan wrote in the New England Journal of Medicine in April 2000, four months after the IOM announcement of a crisis:
- "I have cautioned against drawing conclusions about the numbers of deaths in these studies."
- "The ability of identifying errors is methodologically suspect."
- "In both studies [New York and Utah/Colorado] we agreed among ourselves about whether events should be classified as preventable. ... These decisions do not necessarily reflect the views of the average physician, and certainly don't mean that all preventable adverse events were blunders." (2)
Other safety experts add the same note of caution. As part of its crusade against non-government health care, the IOM announced a major safety problem with adverse drug events (ADEs). Jerry Avorn, M.D., an expert on drug events, writing in the Journal of the American Medical Association (JAMA), said in an editorial about a couple of ADE reports: "These two studies push hard at the boundaries of clinical epidemiology and health services research, and a skeptic might wonder whether the envelopes of these disciplines might not have gotten a bit nicked in the process." (3)
Dr. David Bates, another safety expert, in a Journal of the American Medical Association editorial commenting on another drug event study, said the ADE studies have problems, such as whether the events are properly identified and evaluated and whether they are really avoidable in a practical sense, particularly in severely ill patients. (4) The millions of drug administrations daily in American hospitals present an opportunity for data-dredging and manipulation.
Only Three Studies
For all the panic that has been raised, there have been only three patient safety studies, conducted in 1974, 1984, and 1992.
The first study was conducted by Don Harper Mills, M.D., J.D., a pathologist and attorney for the California Medical Association. With three associate attorney/physicians, he looked at care in California hospitals in 1974. They studied about 20,000 patient charts. (5)
The second study examined care in New York hospitals in 1984. It was conducted by a group from Harvard that included Dr. Brennan and Lucien Leape, M.D. They studied 30,000 charts. (6,7,8)
The third study reported on patient care in Utah and Colorado hospitals in 1992. It was the Harvard group's second study, led by Dr Brennan. They looked at 15,000 charts. (9-13)
All these studies showed the same results with only slight differences: a 1 percent rate of negligence events of some kind and less than a 0.25 percent rate of negligent injury or death.
I reviewed a study of 300,000 hospital charts by the Texas Medical Foundation (TMF) from 1989 to 1992 and found even lower numbers of negligence and injury in a higher-risk patient group: the elderly. The California (1974) and Harvard (1984,1992) studies found a rate of 0.25 percent cases with negligence injury or death. In the TMF study the rate was even lower, less than 0.2 percent, and the much larger Utah/Colorado study from 1992 showed some improvement, a decline in the rate of negligence and injury or death. (14-17)
There is no patient safety crisis in the United States. Nurses, doctors, and hospitals aren't killers; they are healers. The current crusade is irresponsible and based on junk science. It is a malicious lie intended to make way for a government takeover of the health care system.
John Dale Dunn, M.D., J.D. teaches emergency medicine at Fort Hood, Texas and is a resident of Brownwood, Texas. He is a policy analyst for The Heartland Institute.
(1) Kohn L.T., Corrigan J.M., Donaldson M.S., eds. To Err is Human--Building a Safer Health System. Washington, DC: National Academy of Science Press; prepublication, November 1999; final publication, 2000.
(2) Brennan T.A. The Institute of Medicine report on medical errors--could it do harm? New England Journal of Medicine 2000;342:1123-1125.
(3) Avorn J. Putting adverse drug events into perspective [editorial]. Journal of the American Medical Association 1997;277:341-342.
(4) Bates D.W. Drugs and adverse drug reactions: how worried should we be? [editorial]. Journal of the American Medical Association 1998;279:1216-1217.
(5) Mills D.H. Medical insurance feasibility study. Western Journal of Medicine 1978;128:360-365.
(6) Brennan T.A., Leape L.L., Laird N.M., et al. Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study I. New England Journal of Medicine 1991;324:370-376.
(7) Leape L.L., Brennan T.A., Laird N.M., et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. New England Journal of Medicine 1991;324:377-384.
(8) Localio A.R., Lawthers A.G., Brennan T.A., et al. Relation between malpractice claims and adverse events due to negligence: results of the Harvard Medical Practice Study III. New England Journal of Medicine 1991;325:245-251.
(9) Gawande A.A., Thomas E.J., Zinner M.J., Brennan T.A. The incidence and nature of surgical adverse events in Colorado and Utah in 1992. Surgery 1999;126:66-75.
(10) Thomas E.J., Studdert D.M., Newhouse J.P., et al. Costs of medical injuries in Utah and Colorado. Inquiry 1999;36:255-264.
(11) Thomas E.J., Brennan T.A. Incidence and types of preventable adverse events in elderly patients: population based review of medical records. British Journal of Medicine 2000;320:741-744.
(12) Thomas E.J., Studdert D.M., Burstin H.R., et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Medical Care 2000;38:261-271.
(13) Studdert D.M., Thomas E.J., Burstin H.R., Zbar B.I., Orav E.J., Brennan T.A. Negligent care and malpractice claiming behavior in Utah and Colorado. Medical Care 2000;38:250-260.
(14) Dunn J.D. Patient safety in America: comparison and analysis of national and Texas patient safety research. Texas Medicine (Oct) 2000; 96:66-74.
(15) Quantum. Annual report to the provider: April 1, 1989-March 31, 1990. Austin, TX: Texas Medical Foundation; 1990:6, fig 10.
(16) Quantum. Annual report to the provider. April 1, 1990-March 31, 1991. Austin, TX: Texas Medical Foundation; 1991:7, fig 10.
(17) Quantum. Annual report to the provider: April 1, 1991-March 31, 1992. Austin, TX: Texas Medical Foundation; 1992:7.