Death by Medicine
Medical Renaissance Group
Deadly Medical Mistakes
Are Number One US Killer
For the first time, new information has been presented showing the
degree to which Americans have been subjected to injury and death by
The results of seven years of research reviewing thousands of studies
conducted by the Nutrition Institute of America show for the first
time that medical errors are the number one cause of death and injury
in the United States.
According to the NIA's report, over 784,000 people die annually due
to medical mistakes. Comparatively, the 2001 annual death rate for
heart disease was 699,697 and the annual death rate for cancer was
553,251. Over 2.2 million people are injured every year by
prescription drugs alone and over 20 million unnecessary
prescriptions for antibiotics are prescribed annually for viral
The report also shows that 7.5 million unnecessary medical and
surgical procedures are performed every year and 8.9 million people
are needlessly hospitalized annually. Based on the results of NIA's
report, it is evident that there is a pressing need for an overhaul
of the entire American medical system.
The findings, described as a 'revelation' by Martin Feldman, MD, who
helped to uncover the evidence, are the product of the first
comprehensive studies on iatrogenic incidents (those caused by the
treatment or drug itself). Never before has any study uncovered such
a massive amount of information about the degree and effect of
iatrogenesis. Historically, only small individual partial studies
have been performed in this area.
Carolyn Dean, MD, a physician and author who also helped to uncover
the findings said, "I was completely shocked, amazed, and dismayed
when I first added up all the statistics on medical death and saw how
much allopathic medicine has betrayed us."
The Nutrition Institute of America is a not-for-profit, non-partisan
organization that has been enlightening the public on health issues
for nearly 30 years. For more information, contact David Slater,
President of NIA at (646) 505 - 4660 ext 155.
Nutrition Institute of America
Death by Medicine
Gary Null PhD, Carolyn Dean MD ND, Martin Feldman MD
Debora Rasio MD, Dorothy Smith PhD
Note: The information on this website is not a substitute for
diagnosis and treatment by a qualified, licensed professional.
NEVER ENOUGH STUDIES
Scientists used the excuse that there were never enough studies
revealing the dangers of DDT and other dangerous pesticides to ban
them. They also used this excuse around the issue of tobacco,
claiming that more studies were needed before they could be certain
that tobacco really caused lung cancer. Even the American Medical
Association (AMA) was complicit in suppressing results of tobacco
research. In 1964, the Surgeon General's report condemned smoking,
however the AMA refused to endorse it. What was their reason? They
needed more research. Actually what they really wanted was more money
and they got it from a consortium of tobacco companies who paid the
AMA $18 million over the next nine years, during which the AMA said
nothing about the dangers of smoking.108
The Journal of the American Medical Association (JAMA), "after
careful consideration of the extent to which cigarettes were used by
physicians in practice," began accepting tobacco advertisements and
money in 1933. State journals such as the New York State Journal of
Medicine also began to run Chesterfield ads claiming that cigarettes
are, "Just as pure as the water you drink. and practically untouched
by human hands." In 1948, JAMA argued "more can be said in behalf of
smoking as a form of escape from tension than against it. there does
not seem to be any preponderance of evidence that would indicate the
abolition of the use of tobacco as a substance contrary to the public
health."109 Today, scientists continue to use the excuse that they
need more studies before they will lend their support to restrict the
inordinate use of drugs.
OVERVIEW OF STATISTICAL TABLES AND FIGURES
Adverse Drug Reactions
The Lazarou study1 was based on statistical analysis of 33 million
U.S. hospital admissions in 1994. Hospital records for prescribed
medications were analyzed. The number of serious injuries due to
prescribed drugs was 2.2 million; 2.1% of in-patients experienced a
serious adverse drug reaction; 4.7% of all hospital admissions were
due to a serious adverse drug reaction; and fatal adverse drug
reactions occurred in 0.19% of in-patients and 0.13% of admissions.
The authors concluded that a projected 106,000 deaths occur annually
due to adverse drug reactions.
We used a cost analysis from a 2000 study in which the increase in
hospitalization costs per patient suffering an adverse drug reaction
was $5,483. Therefore, costs for the Lazarou study's 2.2 million
patients with serious drug reactions amounted $12 billion.1,49
Serious adverse drug reactions commonly emerge after Food and Drug
Administration approval. The safety of new agents cannot be known
with certainty until a drug has been on the market for many years.110
Over one million people develop bedsores in U.S. hospitals every
year. It's a tremendous burden to patients and family, and a $55
billion dollar healthcare burden.7 Bedsores are preventable with
proper nursing care. It is true that 50% of those affected are in a
vulnerable age group of over 70. In the elderly bedsores carry a
fourfold increase in the rate of death. The mortality rate in
hospitals for patients with bedsores is between 23% and 37%.8 Even if
we just take the 50% of people over 70 with bedsores and the lowest
mortality at 23%, that gives us a death rate due to bedsores of
115,000. Critics will say that it was the disease or advanced age
that killed the patient, not the bedsore, but our argument is that an
early death, by denying proper care, deserves to be counted. It is
only after counting these unnecessary deaths that we can then turn
our attention to fixing the problem.
Malnutrition in Nursing Homes
The General Accounting Office (GAO), a special investigative branch
of Congress, gave citations to 20% of the nation's 17,000 nursing
homes for violations between July 2000 and January 2002. Many
violations involved serious physical injury and death.111
A report from the Coalition for Nursing Home Reform states that at
least one-third of the nation's 1.6 million nursing home residents
may suffer from malnutrition and dehydration, which hastens their
death. The report calls for adequate nursing staff to help feed
patients who aren't able to manage a food tray by themselves.11 It is
difficult to place a mortality rate on malnutrition and dehydration.
This Coalition report states that malnourished residents, compared
with well-nourished hospitalized nursing home residents, have a five-
fold increase in mortality when they are admitted to hospital. So, if
we take one-third of the 1.6 million nursing home residents who are
malnourished and multiply that by a mortality rate of 20%,8,14 we
find 108,800 premature deaths due to malnutrition in nursing homes.
The rate of nosocomial infections per 1,000 patient days has
increased 36% - from 7.2 in 1975 to 9.8 in 1995. Reports from more
than 270 U.S. hospitals showed that the nosocomial infection rate
itself had remained stable over the previous 20 years with
approximately five to six hospital-acquired infections occurring per
100 admissions, which is a rate of 5-6%. However, because of
progressively shorter inpatient stays and the increasing number of
admissions, the actual number of infections increased. It is
estimated that in 1995, nosocomial infections cost $4.5 billion and
contributed to more than 88,000 deaths - one death every 6 minutes.9
The 2003 incidence of nosocomial mortality is quite probably higher
than in 1995 because of the tremendous increase in antibiotic-
resistant organisms. Morbidity and Mortality Report found that
nosocomial infections cost $5 billion annually in 1999.10 This is a
$0.5 billion increase in four years. The present cost of nosocomial
infections might now be in the order of $5.5 billion.
Dr. Barbara Starfield in a 2000 JAMA paper presents us with well-
documented facts that are both shocking and unassailable.12
1. The U.S. ranks twelfth out of 13 countries in a total of 16 health
indicators. Japan, Sweden, and Canada were first, second, and third.
2. More than 40 million people have no health insurance.
3. 20% to 30% of patients receive contraindicated care.
Dr. Starfield warns that one cause of medical mistakes is the overuse
of technology, which may create a "cascade effect" leading to more
treatment. She urges the use of ICD (International Classification of
Diseases) codes which have designations called: "Drugs, Medicinal,
and Biological Substances Causing Adverse Effects in Therapeutic Use"
and "Complications of Surgical and Medical Care" to help doctors
quantify and recognize the magnitude of the medical error problem.
Starfield says that, at present, deaths actually due to medical error
are likely to be coded according to some other cause of death.
She concludes that against the backdrop of our abysmal health report
card compared to the rest of the Westernized countries, we should
recognize that the harmful effects of health care interventions
account for a substantial proportion of our excess deaths.
Starfield cites Weingart's 2000 article, "Epidemiology of Medical
Error" on outpatient iatrogenesis. And Weingart, in turn, cites
several authors and provides statistics showing that between 4% to
18% of consecutive patients in outpatient settings suffer an
iatrogenic event leading to:112
1. 116 million extra physician visits
2. 77 million extra prescriptions
3. 17 million emergency department visits
4. 8 million hospitalizations
5. 3 million long-term admissions
6. 199,000 additional deaths
7. $77 billion in extra costs
There are 12,000 deaths per year from unnecessary surgeries. However,
results from the few studies that have measured unnecessary surgery
directly indicate that for some highly controversial operations, the
fraction that are unwarranted could be as high as 30%.74
IT'S A GLOBAL ISSUE
A survey published in the Journal of Health Affairs pointed out that
between 18% and 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 in five different countries. The breakdown by
country showed 18% of those in Britain, 25% in Canada, 23% in
Australia, 23% in New Zealand, and the highest number was in the U.S.
A recent finding by the Institute of Medicine is that the 41 million
Americans without health insurance have consistently worse clinical
outcomes than those that are insured, and are at increased risk for
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 U.S. General Accounting Office (GAO) gave a 1998
figure of $12 billion dollars lost to fraudulent or unnecessary
claims, 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.115
WAREHOUSING OUR ELDERS
It is only fitting that we end this report with acknowledgement of
our elders. The moral and ethical fiber of society can be judged by
the way it treats its weakest and most vulnerable members. Some
cultures honor and respect the wisdom of their elders, keeping them
at home - the better to continue participation in their community.
However, American nursing homes, where millions of our elders die,
represent the pinnacle of social isolation and medical abuse.
Important Statistics about Nursing Homes
1. In America, at any one time, approximately 1.6 million elderly are
confined to nursing homes. By 2050 that number could be 6.6
2. A total of 20% of all deaths from all causes occur in nursing
3. Hip fractures are the single greatest reason for nursing home
admissions.118 Nursing homes represent a reservoir for drug-resistant
organisms due to overuse of antibiotics.119
Congressman Waxman reminded us that "as a society we will be judged
by how we treat the elderly" when he presented a report that he
sponsored, "Abuse of Residents is a Major Problem in U.S. Nursing
Homes," on July 30, 2001. The report uncovered that one third - 5,283
of the nations' 17,000 nursing homes - were cited for an abuse
violation in the two-year period studied, January 1999 - January
2001.116 Waxman stated that "the people who cared for us, deserve
better." He also made it very clear that this was only the tip of the
iceberg and there is much more abuse occurring that we don't know
about or ignore.116a
The major findings of "Abuse of Residents is a Major Problem in U.S.
Nursing Homes," were:
4. Over 30% of nursing homes in the U.S. were cited for abuses,
totaling more than 9,000 abuse violations.
5. 10% of nursing homes had violations that caused actual physical
harm to residents, or worse.
6. Over 40%, or 3,800 abuse violations were only discovered after a
formal complaint was filed, usually by concerned family members.
7. Many verbal abuse violations were found.
8. Occasions of sexual abuse.
9. Incidents of physical abuse causing numerous injuries such as
fractured femur, hip, elbow, wrist, and other injuries.
Dangerously understaffed nursing homes lead to neglect, abuse,
overuse of medications, and physical restraints. An exhaustive study
of nurse-to-patient ratios in nursing homes was mandated by Congress
in 1990. The study was finally begun in 1998 and took four years to
complete.120 Commenting on the study, a spokesperson for The National
Citizens' Coalition for Nursing Home Reform said, "They compiled two
reports of three volumes each thoroughly documenting the number of
hours of care residents must receive from nurses and nursing
assistants to avoid painful, even dangerous, conditions such as
bedsores and infections. Yet it took the Department of Health and
Human Services and Secretary Tommy Thompson only four months to
dismiss the report as `insufficient.'"121 Bedsores occur three times
more commonly in nursing homes than in acute care or veterans'
hospitals.122 But we know that bedsores can be prevented with proper
nursing care. It shouldn't take four years for someone to find out
that proper care of bedsores requires proper staffing. In spite of
such urgent need in nursing homes where additional staff could solve
so many problems, we hear the familiar refrain "not enough research" -
one that merely buys time for those in charge and relegates another
smoldering crisis to the back burner.
Since many nursing home patients suffer from chronic debilitating
conditions, their assumed cause of death is often unquestioned by
physicians. Some studies show that as many as 50% of deaths due to
restraints, falls, suicide, homicide, and choking in nursing homes
may be covered up.123,124 It is quite possible that many nursing home
deaths are attributed, instead, to heart disease, which, until our
report, was the number one cause of death. In fact, researchers have
found that heart disease may be over-represented in the general
population as a cause of death on death certificates by 7.9% to
24.3%. In the elderly the over-reporting of heart disease as a cause
of death is as much as two-fold.125
When elucidating iatrogenesis in nursing homes, some critics have
asked, "To what extent did these elderly people already have life-
threatening diseases that led to their premature deaths anyway?" Our
response is that if a loved one dies one day, one week, one year, a
decade, or two decades prematurely, thanks to some medical
misadventure, that is still a premature, iatrogenic death. In a
legalistic sense perhaps more weight is placed on the loss of many
potential years compared to an additional few weeks, but this
attitude is not justified in an ethical or moral sense.
The fact that there are very few statistics on malnutrition in acute-
care hospitals and nursing homes shows the lack of concern in this
area. A survey of the literature turns up very few American studies.
Those that do appear are foreign studies in Italy, Spain, and Brazil.
However, there is one very revealing American study conducted over a
14-month period that evaluated 837 patients in a 100-bed sub-acute-
care hospital for their nutritional status. Only 8% of the patients
were found to be well nourished. Almost one-third (29%) were
malnourished and almost two-thirds (63%) were at risk of
malnutrition. The consequences of this state of deficiency were that
25% of the malnourished patients required readmission to an acute-
care hospital compared to 11% of the well-nourished patients. The
authors concluded that malnutrition reached epidemic proportions in
patients admitted to this sub-acute-care facility.126
Many studies conclude that physical restraints are an underreported
and preventable cause of death. Whereas administrators say they must
use restraints to prevent falls, in fact, they cause more injury and
death because people naturally fight against such imprisonment.
Studies show that compared to no restraints, the use of restraints
carries a higher mortality rate and economic burden.127-129 Studies
found that physical restraints, including bedrails, are the cause of
at least 1 in every 1,000 nursing-home deaths.130-132
However, deaths caused by malnutrition, dehydration, and physical
restraints are rarely recorded on death certificates. Several studies
reveal that nearly half of the listed causes of death on death
certificates for older persons with chronic or multi-system disease
are inaccurate.133 Even though 1-in-5 people die in nursing homes,
the autopsy rate is only 0.8%.134 Thus, we have no way of knowing the
true causes of death.
The CDC may be focused on reducing the number of prescriptions for
children but a 2003 study finds over-medication of our elderly
population. Dr. Robert Epstein, chief medical officer of Medco Health
Solutions Inc. (a unit of Merck & Co.), conducted the study on drug
trends.135 He found that seniors are going to multiple physicians and
getting multiple prescriptions and using multiple pharmacies. Medco
oversees drug-benefit plans for more than 60 million Americans,
including 6.3 million senior citizens who received more than 160
million prescriptions. According to the study, the average senior
receives 25 prescriptions annually. In those 6.3 million seniors, a
total of 7.9 million medication alerts were triggered: less than one-
half that number, 3.4 million, were detected in 1999. About 2.2
million of those alerts indicated excessive dosages unsuitable for
senior citizens, and about 2.4 million alerts indicated clinically
inappropriate drugs for the elderly. Reuters interviewed Kasey
Thompson, director of the Center on Patient Safety at the American
Society of Health System Pharmacists, who said, "There are serious
and systemic problems with poor continuity of care in the United
States." He says this study shows "the tip of the iceberg" of a
According to Drug Benefit Trends, the average number of prescriptions
dispensed per non-Medicare HMO member per year rose 5.6% from 1999 to
2000 - from 7.1 to 7.5 prescriptions. The average number dispensed
for Medicare members increased 5.5% - from 18.1 to 19.1
prescriptions.136 The number of prescriptions in 2000 was 2.98
billion, with an average per person prescription amount of 10.4
In a study of 818 residents of residential care facilities for the
elderly, 94% were receiving at least one medication at the time of
the interview. The average intake of medications was five per
resident; the authors noted that many of these drugs were given
without a documented diagnosis justifying their use.138
Unfortunately, seniors, and groups like the American Association for
Retired Persons (AARP), appear to be dependent on prescription drugs
and are demanding that coverage for drugs be a basic right.139 They
have accepted the overriding assumption from allopathic medicine that
aging and dying in America must be accompanied by drugs in nursing
homes and eventual hospitalization with tubes coming out of every
orifice. Instead of choosing between drugs and a diet-lifestyle
change, seniors are given the choiceless option of either high-cost
patented drugs or low-cost generic drugs. Drug companies are
attempting to keep the most expensive drugs on the shelves and to
suppress access to generic drugs, in spite of stiff fines of hundreds
of millions of dollars from the government.140,141 In 2001 some of
the world's biggest drug companies, including Roche, were fined a
record £523 million ($871 million) for conspiring to increase the
price of vitamins.142
We would urge AARP, especially, to become more involved in prevention
of disease and not to rely so heavily on drugs. At present, the AARP
recommendations for diet and nutrition assume that seniors are
getting all the nutrition they need in an average diet. At most, they
suggest extra calcium and a multiple vitamin/mineral supplement.143
This is not enough, and in our next report we will show how to live a
healthier life without unnecessary medical intervention.
We would like to send the same message to the Hemlock Society, which
offers euthanasia options to chronically ill people, especially those
in severe pain. What if some of these chronic diseases are really
lifestyle diseases caused by deficiency of essential nutrients, lack
of care, inappropriate medication, or lack of love? This question is
extremely important to consider when you are depressed or in pain. We
must look to healing those conditions before offering up our lives.
Let's also look at the irony of under use of proper pain medication
for patients that really need it. For example, in one particular
study pain management was evaluated in a group of 13,625 cancer
patients, aged 65 or over, living in nursing homes. Overall, almost
30%, or 4,003 patients, reported pain. However, more than 25%
received absolutely no pain relief medication; 16% received a World
Health Organization (WHO) level-one drug (mild analgesic); 32% a WHO
level-two drug (moderate analgesic); and only 26% received adequate
pain relieving morphine. The authors concluded that older patients
and minority patients were more likely to have their pain
The time has come to set a standard for caring for the vulnerable
among us - a standard that goes beyond making sure they are housed
and fed, and not openly abused. We must stop looking the other way
and we, as a society, must take responsibility for the way in which
we deal with those who are unable to care for themselves.
WHAT REMAINS TO BE UNCOVERED
Our ongoing research will continue to quantify the morbidity,
mortality, and financial loss due to:
10. X-ray exposures: mammography, fluoroscopy, CT scans.
11. Overuse of antibiotics in all conditions.
12. Drugs that are carcinogenic: hormone replacement therapy (*see
below), immunosuppressive drugs, prescription drugs.
13. Cancer chemotherapy: If it doesn't extend life, is it shortening
14. Surgery and unnecessary surgery: Cesarean section, radical
mastectomy, preventive mastectomy, radical hysterectomy,
prostatectomy, cholecystectomies, cosmetic surgery, arthroscopy, etc.
15. Discredited medical procedures and therapies.
16. Unproven medical therapies.
17. Outpatient surgery.
18. Doctors themselves: when doctors go on strike, it appears the
mortality rate goes down.
*Part of our ongoing research will be to quantify the mortality and
morbidity caused by hormone replacement therapy (HRT) since the mid-
1940's. In December 2000, a government scientific advisory panel
recommended that synthetic estrogen be added to the nation's list of
cancer-causing agents. HRT, either synthetic estrogen alone or
combined with synthetic progesterone, is used by an estimated 13.5 to
16 million women in the U.S.145 The aborted Women's Health Initiative
Study (WHI) of 2002 showed that women taking synthetic estrogen
combined with synthetic progesterone have a higher incidence of
ovarian cancer, breast cancer, stroke, and heart disease and little
evidence of osteoporosis reduction or prevention of dementia. WHI
researchers, who usually never give recommendations, other than
demanding more studies, are advising doctors to be very cautious
about prescribing HRT to their patients.100,146-150
Results of the "Million Women Study" on HRT and breast cancer in the
U.K were published in the Lancet, August, 2003. Lead author,
Professor Valerie Beral, Director of the Cancer Research UK
Epidemiology Unit, is very open about the damage HRT has caused. She
said, "We estimate that over the past decade, use of HRT by UK women
aged 50-64 has resulted in an extra 20,000 breast cancers, oestrogen-
progestagen (combination) therapy accounting for 15,000 of these."151
However, we were not able to find the statistics on breast cancer,
stroke, uterine cancer, or heart disease due to HRT used by American
women. The population of America is roughly six times that of the
U.K. Therefore, it is possible that 120,000 cases of breast cancer
have been caused by HRT in the past decade.
When the number one killer in a society is the healthcare system,
then, that system has no excuse except to address its own urgent
shortcomings. It's a failed system in need of immediate attention.
What we have outlined in this paper are insupportable aspects of our
contemporary medical system that need to be changed - beginning at
its very foundations.
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OFFICE OF TECHNOLOGY ASSESSMENT (OTA)
Health Care Technology and Its Assessment in Eight Countries, 1995.
1. In 1990 life expectancy in the U.S. was 71.8 years for men and
78.8 for women, among the lowest of the developed countries.
2. The 1990 infant mortality rate was 9.2 per 1,000 live births. This
was in the bottom half of the distribution among all developed
countries. (OTA comments on the frustration of poor statistics and
high healthcare spending.)
3. Health status is correlated with socioeconomic status.
4. Healthcare is not universal.
5. Healthcare is based on the free market system with no fixed budget
or limitations on expansion.
6. Healthcare accounts for 14% of the U.S. GNP, which was over $800
billion in 1993.
7. The federal government does no central planning. It is the major
purchaser of health care for older people and some poor people.
8. Americans have a lower level of satisfaction with their healthcare
system than people in other developed countries.
9. U.S. medicine specializes in expensive medical technology. Some
major U.S. cities have more MRI scanners than most countries.
10. Huge public and private investment in medical research and
pharmaceutical development drives this "technological arms race."
11. Any efforts to restrain technological developments in healthcare
are opposed by policy makers concerned about negative impacts on
12. In 1990 there were: 5,480 acute-care hospitals, 880 specialty
hospitals (psychiatric, long-term care, rehab) and 340 federal
hospitals (military, vets and Native Americans) providing 2.7
hospitals per 100,000 population.
13. In 1990 the average length of stay for an annual 33 million
admissions was 9.2 days. Bed occupancy rate was 66%. Lengths of stay
were shorter and admission rates lower than other countries.
14. In 1990 there were 615,000 physicians, 2.4 per 1,000; 33% were
primary care (family medicine, internal medicine, and pediatrics) and
67% were specialists.
15. In 1991 government-run healthcare spending was $81 billion.
16. Total healthcare spending was $752 billion in 1991, an increase
from $70 billion in 1950. Spending grew five-fold per capita.
17. Reasons for increased healthcare spending:
a. The high cost of defensive medicine, with an escalation in
services solely to avoid malpractice litigation.
b. U.S. healthcare based on defensive medicine costs nearly $45
billion per year, or about 5% of total healthcare spending, according
to one source.
c. The availability and use of new medical technologies have
contributed the most to increased healthcare spending, argue many
analysts. OTA admits that these costs are impossible to quantify.
18. The reasons government attempts to control healthcare costs have
a. Market incentive and profit-motive involvement in the financing
and organization of healthcare including private insurance, hospital
system, physician services, and drug and medical device industries.
b. Expansion is the goal of free enterprise.
Health-Related Research and Development
19. The U.S. spends more than any other country on R & D.
20. $9.2 billion was spent in 1989 by the federal government; U.S.
industries spent an additional $9.4 billion.
21. There was a 50% rise in total national R & D expenditures between
1983 and 1992.
22. NIH receives about half of the government funding.
23. NIH spent more on basic research ($4.1 billion in 1989) than for
clinical trials of medical treatments on humans ($519 million in
24. Most of the trials evaluate new cancer treatment protocols and
new treatments for complications of AIDS and do not study existing
treatments, even though the effectiveness of many of them is unknown
25. The NIH in 1990 had just begun to do meta-analysis and cost-
Pharmaceutical and Medical Device Industry
26. About two-thirds of the industry's $9.4 billion budget went to
drug research; the remaining one-third was spent by device
27. In addition to R & D, the medical industry spent 24% of total
sales on promoting their products and only 15% of total sales on
28. Total marketing expenses in 1990 were over $5 billion.
29. Many products provide no benefit over existing products.
30. Public and private healthcare consumers buy these products.
31. If healthcare spending is perceived as a problem, a highly
profitable drug industry exacerbates the problem.
Controlling Health Care Technology
32. The FDA ensures the safety and efficacy of drugs, biologics, and
33. The FDA does not consider costs of therapy.
34. The FDA does not consider the effectiveness of a therapy.
35. The FDA does not compare a product to currently marketed products
36. The FDA does not consider non-drug alternatives for a given
37. Drug development costs $200 million to bring a new drug to
market. AIDS-drug interest groups forced new regulations that speed
up the approval process.
38. Such drugs should be subject to greater post-marketing
surveillance requirements. But as of 1995 these provisions had not
yet come into play.
39. Many argue that reductions in the pre-approval testing of drugs
opens the possibility of significant undiscovered toxicities.
Health Care Technology Assessment
40. Failure to evaluate technology was a focus of a 1978 report from
OTA with examples of many common medical practices supported by
limited published data. (10-20%)
41. In 1978 congress created the National Center for Health Care
Technology (NCHCT) to advise Medicare and Medicaid.
42. With an annual budget of $4 million NCHCT published three broad
assessments of high-priority technologies and made about 75 coverage
recommendations to Medicare.
43. NCHCT was put out of business by Congress in 1981-a political
casualty. The medical profession opposed it from the beginning. The
AMA testified before Congress in 1981 that "clinical policy analysis
and judgments are better made-and are being responsibly made-within
the medical profession. Assessing risks and costs, as well as
benefits, has been central to the exercise of good medical judgment
44. The medical device lobby also opposed government oversight by
Examples of Lack of Proper Management of HealthCare
1. Treatments for Coronary Artery Disease
45. Since the early 1970's the number of coronary artery-bypass
surgeries (CABGS) has risen rapidly without government regulation and
without clinical trials.
46. Angioplasty for single vessel disease was introduced in 1978. The
first published trial of angioplasty versus medical treatment was in
47. Angioplasty did not cut down on the number of CABGS as was
48. Both procedures increase in number every year as the patient
population grows older and sicker.
49. Rates of use are higher in white patients, in private insurance
patients, and there is great variation in different geographic
regions. Such facts imply that use of these procedures is based on
50. At the time of this report, 1995, the NIH consensus program had
not assessed CABGS since 1980 and had never assessed angioplasty.
51. RAND researchers evaluated CABGS in New York in 1990. They
reviewed 1,300 procedures and found 2% were inappropriate, 90%
appropriate, and 7% uncertain. For 1,300 angioplasties, 4% were
inappropriate and 38% uncertain. Using RAND methodologies a panel of
British physicians rated twice as many procedures "inappropriate" as
did a U.S. panel rating the same clinical cases. The New York numbers
are in question because New York State limits the number of surgery
centers, and the per-capita supply of cardiac surgeons in New York is
about one-half the national average.
52. The estimated five-year cost is $33,000 for angioplasty and
$40,000 for CABGS. So, angioplasty did not lower costs. This was
because of high failure rates of angioplasty.
2. Computed Tomography CT
53. The first CT scanner in the U.S. was installed at the Mayo Clinic
in 1973. In 1992 the number of operational CT scanners was 6,060. By
comparison, in 1993 there were 216 CT units in Canada.
54. There is little information available on how CT scan improves or
affects patient outcome.
55. In some institutions up to 90% of scans performed were negative.
56. Approval by the FDA was not required for CT scanners. No evidence
of safety or efficacy was required.
57. The first MRI was introduced in 1978 in Great Britain; the first
U.S. scanner in 1980. By 1988 there were 1,230 units; by 1992 between
2,800 and 3,000.
58. A definitive review published in 1994 found less than 30 studies
out of 5,000 that were prospective comparisons of diagnostic accuracy
or therapeutic choice.
59. American College of Physicians assessed MRI studies and rated 13
out of 17 trials as "weak" - meaning the absence of any studies on
therapeutic impact or patient outcomes.
60. The OAT concludes that, "It is evident that hospitals, physician-
entrepreneurs, and medical device manufacturers have approached MRI
and CT as commodities with high-profit potential, and decision-making
on the acquisition and use of these procedures has been highly
influenced by this approach. Clinical evaluation, appropriate patient
selection, and matching supply to legitimate demand might be viewed
as secondary forces."
4. Laparoscopic Surgery
61. Laparoscopic cholecystectomy was introduced at a professional
surgical society meeting in late 1989. In 1992, five years after
introduction, 85% of all cholecystectomies were performed
62. There was an associated increase of 30% in the number of
63. Because of the increased volume of gall bladder operations, the
total costs increased 11.4% between 1988 and 1992, in spite of a
25.1% drop in the average cost per surgery.
64. The mortality rate for gall bladder surgeries also did not
decline as a result of the lower risk because so many more were
65. When studies were finally done on completed cases, the results
showed that laparoscopic cholecystectomy was associated with reduced
in-patient duration, decreased pain, and shorter period of restricted
activity. But there were increased rates of bile duct and major
vessel injuries and a suggestion that these rates were worse for
people with acute cholecystitis. There were still no clinical trials
to clarify this issue.
66. Patient demand, fueled by substantial media attention, was a
major force in promoting rapid adoption.
67. The video, which introduced the procedure in 1989, was produced
by the major manufacturer of laparoscopic equipment.
68. Doctors were given two-day training seminars before performing
the surgery on patients.
69. In 1990 the U.S. ranked twenty-fourth in infant mortality out of
38 developed countries with a rate of 9.2 deaths per 1,000 live
70. U.S. black infant mortality is 18.6 per 1,000 live births and 8.8
Screening for Breast Cancer
71. There has always been a debate over mammography screening in
women under 50.
72. In 1992 the Canadian National Breast Cancer Study of 50,000 women
showed that mammography had no effect on mortality for younger women,
73. The National Cancer Institute (NCI) refused to change its
recommendations on mammography.
74. The American Cancer Society decided to wait for more studies on
75. Then, in December 1993 NCI announced that women over 50 should
have routine screening every one to two years but younger women would
have no benefit from having mammography.
76. The OTA concluded that, "There are no mechanisms in place to
limit dissemination of technologies regardless of their clinical
Shortly after this report, the OTA was disbanded.
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