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MAD COW DISEASE AND HUMANS
When a new form of an old human disease appeared in England in 1995, some medical specialists immediately suspected that it might be a human version of "mad cow disease," but they had no proof.[1] Mad cow disease had appeared in British dairy cattle for the first time in 1985 and during the subsequent decade 175,000 British cows had died from it. British health authorities spent that decade reassuring the public that there was no danger from eating the meat of infected cows. They said a "species barrier" prevented mad cows from infecting humans. A "species barrier" does prevent many diseases from crossing from one species to another -- for example, measles and canine distemper are closely related diseases, but dogs don't get measles and humans don't get distemper.
While the British government was placing its faith in the species barrier, British citizens began to die of a new disease, called "new variant Creutzfeld-Jakob disease" or nvCJD. A similar disease, CJD (Creutzfeld-Jakob disease) had been recognized for a long time but it almost never occurs in people younger than 30; nvCJD, on the other hand, strikes people as young as 13. There are several other differences between CJD and nvCJD, so nvCJD represents something new. To date, nvCJD has killed 48 people in England and one or two others elsewhere in Europe. The main feature of both mad cow disease and nvCJD is the progressive destruction of brain cells, inevitably leading to total disability and death.
New research published late in 1999 showed that nvCJD is, in fact, a human form of mad cow disease,[2] dashing all hope that a species barrier can protect humans from this deadly bovine affliction.
Mad cow disease is formally known as "bovine spongiform encephalopathy" or BSE. BSE is the cow version of a larger class of diseases called "transmissible spongiform encephalopathies," or TSEs. TSEs can afflict sheep, deer, elk, cows, mink, cats, squirrels, monkeys, humans and other species. In all species the symptoms of TSEs are the same -- progressive destruction of brain cells leading to dementia and death.
Traditional Creutzfeld-Jakob disease (CJD) is a rare human affliction. The visible symptoms are similar to Alzheimer's disease; in fact, CJD is sometimes diagnosed as Alzheimer's and therefore may go unrecognized. CJD strikes one in a million people almost all of whom are older than 55. In people younger than age 30, CJD is extremely rare, striking an average of 5 people per billion each year, worldwide (not counting the recent outbreak in England).
In cows, the latency (or incubation) period for mad cow disease is about 5 years, meaning that cows have the disease for five years before symptoms begin to appear. No one knows the latency period for nvCJD in humans, but it is thought to be around 10 years. Because of this uncertainty, no one is sure how many people in England already have the disease but are not yet showing symptoms. The British government's chief medical officer, Professor Liam Donaldson, said December 21, 1999, "We're not going to know for several years whether the size of the epidemic will be a small one, in other words in the hundreds, or a very large one, in the hundreds of thousands."
The epidemic of mad cow disease was caused by an agricultural innovation -- feeding dead cows to live cows. Cows are, by nature, vegetarians. But modern agricultural techniques changed that. Cows that died mysteriously were sent to rendering plants where they were boiled down and ground up into the consistency of brown sugar, and eventually added to cattle feed. It was later determined that mad cow disease was being transmitted through such feed, and especially through certain specific tissues -- brain, spinal cord, eyes, spleen and perhaps other nerve tissues.
Ten new cases of nvCJD were reported in England in 1999, bringing the total to 48. It has been more than 10 years since government authorities banned the use of the particular parts of cows thought to transmit mad cow disease. The appearance of new cases of nvCJD in 1999 implies either that the latency period for the disease is longer than 10 years, or that infected meat was not effectively eliminated from the food chain when government authorities said it was, or both.
The SUNDAY TIMES of London reported in late December that some meat banned for human consumption is still being marketed in England. After the mad cow scandal erupted, the British government attempted to eradicate the disease by requiring that all cows older than 30 months be slaughtered. As a result, by last September more than 2.5 million British cows had been killed. But the TIMES reported that British investigators have documented at least 50 cases of farmers and cattle dealers using bogus identity documents to falsify the ages of cows in order to sell them for human consumption. Furthermore, the Agriculture Ministry acknowledged that as many as 90,000 cattle could not be accounted for. About 1600 new cases of mad cow disease are still being reported each year in England.
In December, French health authorities announced finding a second case of nvCJD, a 36-year-old woman in Paris. France has continued to refuse to import British beef, even though the European Union on August 1, 1999, formally declared British beef as safe as any in the European Union. The European Union said in December it will take France to the European Court of Justice to force it to import British beef. Germany is also refusing to import British beef.
The U.S. government says mad cow disease has never been observed in any U.S. cows. However, a closely-related TSE disease, called chronic wasting disease (CWD), has been increasing for almost 20 years among wild deer and elk in northern Colorado and southern Wyoming. Since 1981, CWD has been spreading slowly among wild deer and elk herds in the Rocky Mountains and now afflicts between 4% and 8% of 62,000 deer in the region between Fort Collins, Colorado and Cheyenne, Wyoming.
During 1999, CWD erupted among a herd of elk on the David Kesler Game Farm near Philipsburg, Montana, which raised elk commercially. A few of Mr. Kesler's elk had been shipped to Oklahoma and Idaho, and perhaps elsewhere, and CWD was discovered in some of those animals, too. In early December, Montana health authorities slaughtered 81 elk on Mr. Kesler's farm. They initially announced plans to incinerate the carcasses, but later decided that incineration would be too expensive. The animals were finally buried at the High Plains Sanitary Landfill north of Great Falls. Equipment used to feed, water and care for the animals was also buried in the landfill. Montana authorities announced that the fenceline at the elk farm would be decontaminated, but they did not say what procedure they would use. Nor did they announce what would become of Mr. Kesler's contaminated land. The disease agent that causes CWD -- a prion protein -- is very hardy and resists destruction by traditional sterilization techniques like alcohol and heat.
The diseased elk carcasses in the High Plains landfill have been buried under a mound of garbage but will still be accessible to rainwater and perhaps to scavenging animals.
In northeastern Colorado and southeastern Wyoming, state officials are urging hunters to protect themselves when dressing wild deer and elk they have shot. Hunters should wear rubber gloves, minimize contact with brain and spinal cord tissues, discard the brain, spinal cord, eyes, spleen and lymph nodes and definitely not eat them. There is no evidence that CWD can cross over from deer and elk to humans, but there was no firm evidence that mad cow disease could afflict humans until 1999, so wildlife officials in the Rocky Mountain states say caution is warranted.
Writing in the BOSTON GLOBE, Terry J. Allen reported in late 1999 that, since 1996, Creutzfeld-Jakob disease has been identified in 3 Americans younger than age 30.[3] All three are known to have hunted extensively or eaten venison. There is no evidence that CWD disease has jumped from deer or elk to humans, but the appearance of this extremely-rare disease in young people was the first evidence of a problem in England, so health authorities in the U.S. say they are aggressively investigating all the possibilities.
A statistician at the federal Centers for Disease Control (CDC) in Atlanta told Terry Allen that, if one more case of CJD had surfaced in a person younger than 30 in the U.S., it "might tip the balance," meaning it might convince authorities that something truly unusual was occurring. Dr. Michael Hansen of Consumer's Union says, "Given how rare the disease is in young people and how difficult it is to make a diagnosis, the possibility that some cases go undetected cannot be ruled out."[3]
Indeed, of the 3 cases detected in the U.S. since 1996, one nearly went undetected. Last year in Utah, Doug McEwan, 28, began to show an array of mysterious symptoms: loss of memory, loss of motor control, mood swings, and disorientation. His wife, Tracey, says his doctors conducted hundreds of tests but could not diagnose his disease. She happened to see a TV program on mad cow disease and she insisted that Doug's doctors must test for CJD. A brain biopsy confirmed the diagnosis.
One of the three young CJD victims had eaten deer shot near Rangely, Maine, so last November federal officials took samples of brains from 299 deer shot in western Maine. Authorities said at the time they were quite sure Maine deer are not harboring CWD. So far, test results have not been released.
Federal authorities have quarantined two herds of sheep in Vermont because they say the sheep may have been given feed that contained parts of animals afflicted by mad cow disease. The sheep had been imported into Vermont from Belgium and the Netherlands, where they may have been fed improperly. A similar herd of sheep in New York state was recently purchased by the federal government and slaughtered.[4]
Meanwhile, a 68-year-old Indiana man with a fondness for beef-brain sandwiches died of CJD last summer. Beef-brain sandwiches are a local delicacy in Indiana, introduced years ago by German immigrants. The EVANSVILLE (INDIANA) COURIER reported that John Hiedingsfelder, a forensic pathologist in Evansville, said he had seen three cases of CJD in the past year. No connection to mad cow disease has been established in the Indiana cases. Roberta Heiman, a staff writer for the EVANSVILLE (INDIANA) COURIER reportedly received a warning from a cattleman's association not to publish any further articles about this subject.
MEDICAL MISTAKES
During 1999 mainstream institutions revealed that one of the biggest killers in the U.S. is medical mistakes.
** The NEW YORK TIMES reported that 5% of people admitted to hospitals, or about 1.8 million people per year, in the U.S. pick up an infection while there.[1] Such infections are called "iatrogenic" -- meaning "induced by a physician," or, more loosely, "caused by medical care." Iatrogenic infections are directly responsible for 20,000 deaths among hospital patients in the U.S. each year, and they contribute to an additional 70,000 deaths, according to the federal Centers for Disease Control (CDC). The dollar cost of iatrogenic infections is $4.5 billion, according to the CDC.
The rate of iatrogenic infections has increased 36% in the past 20 years[1] partly because people entering hospitals now are sicker and more vulnerable then they were 20 years ago, and partly because excessive use of antibiotics has created antibiotic-resistant killer microbes.
** A large part of the problem is health care workers who fail to wash their hands properly, the TIMES reported. "Hands are the most dangerous thing in the hospital," says Dr. Robert A. Weinstein, director of infectious diseases for the Cook County Bureau of Health Services in Chicago. A study conducted at the Duke University Medical Center found that only 17% of physicians treating patients in an intensive care unit washed their hands appropriately.[1]
An alternative to hand-washing would be use of latex gloves. Unfortunately, many health care workers view gloves as protecting themselves exclusively -- they put them on in the morning and wear them all day long, the equivalent of not washing their hands. A study of glove use at a long-term care center found that gloves were worn 82% of the time when their use was indicated, but changed appropriately only 16% of the time.
Hospitals have few incentives to monitor infection rates among their patients. "If you don't do good [infection] surveillance, you don't detect infections, which means they don't exist and you look great," says Dr. William Jarvis, chief of the Investigation and Prevention branch of the Hospital Infections Program at the CDC in Atlanta.[1]
Various remedies are being considered. One is to urge health care workers to wash their hands with waterless, alcohol-based antimicrobial hand rubs which are as effective as traditional hand-washing but faster to use and gentler than soap and water.
Another approach is to train patients to ask each health care worker who comes into their room, "Did you wash your hands?"
The "big picture" of medical mistakes is even worse. A report entitled, TO ERR IS HUMAN, issued by the National Institute of Medicine (a division of the National Academy of Sciences) in November found that medical mistakes kill somewhere between 44,000 and 98,000 people (average: 71,000) in hospitals in the U.S. each year.[2]
There are about 33.6 million people admitted to hospitals each year in the U.S. Somewhere between 2.9% and 3.7% (average: 3.3%) of these suffer an "adverse event" while in the hospital.[2,pg.1] An "adverse event" is defined as an injury caused by medical management rather than by the underlying disease or condition of the patient.[2,pg.25] Of these adverse events, somewhere between 8.8% and 13.6% (average: 11.2%) are fatal.[2,pg.1] Of all adverse events, somewhere between 53% and 58% (average: 55.5%) are attributable to mistakes.[2,pg.22] Therefore we can calculate[3] that, on average, one out of every 500 people admitted to a hospital in the U.S. is killed by mistake. (For comparison, the chance of being killed in a commercial airline accident is one per 8 million flights.) Thus medical mistakes qualify as a major public health problem. Even the low estimate, 44,000 killed by medical mistakes each year, exceeds the number of people killed in the U.S. by automobile accidents (43,458 in 1998).
For those who are accustomed to thinking in terms of 1-in-a-million as an "acceptable" death rate for technological errors, the 1-in-500 deaths by medical mistakes equates to 2000-in-a-million.
TO ERR IS HUMAN acknowledges that the 1-in-500 figure may underestimate the size of the death-by-medical-mistake problem because the 1-in-500 estimate is based on information found in patient records and many medical mistakes may not be acknowledged in patient records. TO ERR IS HUMAN says, "Most errors and safety issues go undetected and unreported, both externally and within health care organizations."[2,pg.37] "Silence surrounds this issue," the report says.[2,pg.2]
TO ERR IS HUMAN provides evidence that the 1-in-500 estimate may be low. The report describes two studies that found rates of death due to medical mistakes that far exceed 1 in 500. One study of 815 patients in a university hospital found that 36% had an iatrogenic illness, defined as "any illness that resulted from a diagnostic procedure, from any form of therapy, or from a harmful occurrence that was not a natural consequence of the patient's disease." Of these 815 patients, 9% had an iatrogenic illness that threatened life or produced considerable disability, and for another 2%, iatrogenic illness was believed to contribute to the patient's death.[2,pg.26] Thus this study found that 10-in-500, or 1-in-50, patients were killed by a medical mistake.
A second study looked at 1047 patients admitted to two intensive care units and one surgical unit in a large teaching hospital. Of the 1047 people studied, 480 (46%) had an "adverse event" where an adverse event was defined as "situations in which an inappropriate decision was made when, at the time, an appropriate alternative could have been chosen."[2,pg.26] For 185 patients (18%), the adverse event was serious, producing disability or death.
An important class of medical mistakes is medication errors -- giving a patient the wrong medication, the wrong dose, or inappropriate combinations of medications. TO ERR IS HUMAN estimates that medication errors both inside and outside hospitals killed 7,391 people in the U.S. in 1993,[2,pg.27] but the report acknowledges that, "Current estimates of the incidence of medication errors are undoubtedly low because many errors go undocumented and unreported."[2,pg.29] The problem seems to be getting worse as doctors prescribe more drugs. Between 1983 and 1993, hospital patient deaths due to medication errors increased 2.4-fold while deaths from medication errors among outpatients increased an astonishing 8-fold.[2,pg.28]
TO ERR IS HUMAN reports that doctors often do not consider possible interactions among drugs that they prescribe to a patient. The report says, "Physicians do not routinely screen for potential drug interactions, even when medication history information is readily available." TO ERR IS HUMAN goes on to describe a study of 424 randomly-selected patients in a hospital emergency room. Nearly half of these patients (199, or 47%) received new medications as a result of their hospital visit and in 10% of those -- 19 individuals, or 4.7% of the study group -- received medications that added "potential adverse interactions." "In all cases," TO ERR IS HUMAN reports, "a medication history was recorded on the patients and available to the physicians."[2,pg.33]
Children and old people are particularly prone to medication errors, mainly related to incorrect doses. In one 4-year study of a pediatric intensive care unit, iatrogenic injury due to a medication error occurred among 3.1% of 2147 children -- a rate of one iatrogenic injury among every 33 intensive care admissions.[2,pg.29]vA 1987 study found that physicians prescribed inappropriate medications for nearly 25 percent of all older people.[2,pg.33]
And physicians are not the only part of this problem. A study of pharmacists in Massachusetts found that in a year's time 2.4 million prescriptions (4% of all prescriptions) were improperly filled at the drug store. Eighty-eight percent of these pharmacist errors involved giving patients the wrong drug or the wrong strength.[4]
Lastly, available data about medication errors probably underestimate the true size of the problem. To ERR IS HUMAN says, "Current estimates of the incidence [occurrence] of medication errors are undoubtedly low because many errors go undocumented and unreported."[2,pg.29]
TO ERR IS HUMAN acknowledges that the true death rate from medical mistakes may exceed 1-in-500 for other reasons. The 1-in-500 figure is the in-hospital death rate. "Although many of the available studies have focused on the hospital setting, medical errors present a problem in any setting, not just hospitals."[2,pg.2] And: "...[L]ittle if any research has focused on errors or adverse events occurring outside of hospital settings, for example, in ambulatory care clinics, surgicenters, office practices, home health, or care administered by patients, their family, and friends at home."[2,pg.25] The death rate from medical mistakes in nursing homes has not been reported. However, one study of medications in nursing homes estimated that, for every dollar spent on prescription drugs, $1.33 is spent treating iatrogenic injuries and deaths caused by those drugs.
To ERR IS HUMAN presents a series of recommendations for improving medical safety. The stated goal is to reduce deaths from medical mistakes in hospitals to 1-in-1000 within 5 years. The recommended way to achieve the goal is to make medical errors expensive: "The combined goal of the recommendations is for the external environment to create sufficient pressure to make errors costly to health care organizations and providers, so they are compelled to take action to improve safety," the report says.[2,pg.3]
Thus the National Academy of Medicine acknowledges that laudable motives ("First do no harm"), good intentions, years of specialized training, and voluntary compliance cannot enforce safety protocols. What works is a hefty monetary penalty.
We should all remember this the next time Congress tries to limit the opportunity for citizens to sue corporations and individuals who sell unsafe products or services, dangerous chemicals, and other hazardous technologies. Tort litigation and stiff penalties provide our best hope of limiting harmful behavior.
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