DEATH BY MEDICINE Part 3

[Guest guest]

DEATH BY MEDICINE Part 3

 

 

THE FIRST IATROGENIC STUDY

 

Dr. Lucian L. Leape opened medicine’s Pandora’s box in

his 1994 JAMA paper, " Error in Medicine " .16 He began

the paper by reminiscing about Florence Nightingale’s

maxim – " first do no harm. " But he found evidence of

the opposite happening in medicine. He found that

Schimmel reported in 1964 that 20% of hospital

patients suffered iatrogenic injury, with a 20%

fatality rate. Steel in 1981 reported that 36% of

hospitalized patients experienced iatrogenesis with a

25% fatality rate and adverse drug reactions were

involved in 50% of the injuries. Bedell in 1991

reported that 64% of acute heart attacks in one

hospital were preventable and were mostly due to

adverse drug reactions. However, Leape focused on his

and Brennan’s " Harvard Medical Practice Study "

published in 1991.16a They found that in 1984, in New

York State, there was a 4% iatrogenic injury rate for

patients with a 14% fatality rate. From the 98,609

patients injured and the 14% fatality rate, he

estimated that in the whole of the U.S. 180,000 people

die each year, partly as a result of iatrogenic

injury. Leape compared these deaths to the equivalent

of three jumbo-jet crashes every two days.

 

Why Leape chose to use the much lower figure of 4%

injury for his analysis remains in question. Perhaps

he wanted to tread lightly. If Leape had, instead,

calculated the average rate among the three studies he

cites (36%, 20%, and 4%), he would have come up with a

20% medical error rate. The number of fatalities that

he could have presented, using an average rate of

injury and his 14% fatality, is an annual 1,189,576

iatrogenic deaths, or over ten jumbo jets crashing

every day.

 

Leape acknowledged that the literature on medical

error is sparse and we are only seeing the tip of the

iceberg. He said 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

commented 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. We

wonder: what is the effect on someone who daily gets

the wrong medication, the wrong dose, the wrong

procedure; how do we measure the accumulated burden of

injury; and when the patient finally succumbs after

the tenth error that week, what is entered on the

death certificate?

 

Leape calculated the rate of error in the intensive

care unit. 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. To some this may not seem

like much, but putting this into perspective, Leape

cited industry standards where in aviation a 0.1%

failure rate would mean 2 unsafe plane landings per

day at O’Hare airport; in the U.S. Mail, 16,000 pieces

of lost mail every hour; or in banking, 32,000 bank

checks deducted from the wrong bank account every

hour.

 

Analyzing why there is so much medical error Leape

acknowledged the lack of reporting. Unlike a jumbo-jet

crash, which gets instant media coverage, hospital

errors are spread out over the country in thousands of

different locations. They are also perceived as

isolated and unusual events. However, the most

important reason that medical error is unrecognized

and growing, according to Leape, was, and still is,

that doctors and nurses are unequipped to deal with

human error, due to 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. We can see how a great deal of sweeping

under the rug takes place since nobody is taught what

to do when medical error does occur. Leape cited

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 medicine " to

fundamentally change the way they think about errors

and why they occur " . It’s been almost a decade since

this groundbreaking work, but the mistakes continue to

soar.

 

One year later, in 1995, a report in JAMA said that,

" Over a million patients are injured in U.S. 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 press conference in 1997 Dr. Leape released a

nationwide poll on patient iatrogenesis conducted by

the National Patient Safety Foundation (NPSF), which

is sponsored by the American Medical Association. The

survey found that more than 100 million Americans have

been impacted directly and indirectly by a medical

mistake. Forty-two percent were directly affected and

a total of 84% personally knew of someone who had

experienced a medical mistake.14 Dr. Leape is a

founding member of the NPSF.

 

Dr. Leape at this press conference also updated his

1994 statistics saying that medical errors in

inpatient hospital settings nationwide, as of 1997,

could be as high as three 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 three

million errors, the annual deaths could be as much as

420,000 for inpatients alone. This does not include

nursing home deaths, or people in the outpatient

community dying of drug side effects or as the result

of medical procedures.

 

ONLY A FRACTION OF MEDICAL ERRORS ARE REPORTED

 

Leape, in 1994, said that he was well aware that

medical errors were not being reported.16 According to

a study in two obstetrical units in the U.K., only

about one quarter of the adverse incidents on the

units are ever reported for reasons of protecting

staff or preserving reputations, or fear of reprisals,

including law suits.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 gives a

very broad guess that surgical incident reports

routinely capture only 5-30% of adverse events. In one

surgical study only 20% of surgical complications

resulted in discussion at Morbidity and Mortality

Rounds.25 From these studies it appears that all the

statistics that are gathered may be substantially

underestimating the number of adverse drug and medical

therapy incidents. It also underscores the fact that

our mortality statistics are actually conservative

figures.

 

An article in Psychiatric Times outlines the stakes

involved with reporting medical errors.26 They 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, testifying before

a House subcommittee about medical errors, said that,

" The full magnitude of their threat to the American

public is unknown. " She added, " 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 under-reporting of errors. The

Psychiatric Times noted that the American Medical

Association is strongly opposed to mandatory reporting

of medical errors.26 If doctors aren’t reporting, what

about nurses? In a survey of nurses, they also did not

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 because they prescribed a drug that caused

harm. 29 However, it is this tremendously flawed

system of voluntary reporting from doctors that we

depend on to know whether a drug or a medical

intervention is harmful.

 

Pharmacology texts will also 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 the 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 not

difficult to understand, why only one in twenty side

effects is reported to either hospital administrators

or the FDA.31,31a

 

If hospitals admitted to the actual number of errors

and mistakes, which is about 20 times what is

reported, they would come under intense scrutiny.32

Jerry Phillips, associate director of the Office of

Post Marketing Drug Risk Assessment at the FDA,

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,

comments that because only 5% of adverse drug

reactions are being reported, there are, in reality,

five million medication reactions each year.34

 

It remains that whatever figure you choose to believe

about the side effects from drugs, all the experts

agree that you have to multiply that by 20 to get a

more accurate estimate of what is really occurring in

the burgeoning " field " of iatrogenic medicine.

 

A 2003 survey is all the more distressing because

there seems to be no improvement in error-reporting

even with all the attention on this topic. Dr.

Dorothea Wild surveyed medical residents at a

community hospital in Connecticut. She found that only

half of the residents were aware that the hospital had

a medical error-reporting system, and the vast

majority didn’t 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. And she adds that error reporting is the first

step in finding out where the gaps in the medical

system are and fixing them. That first baby step has

not even begun.35