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LE Magazine March 2004

Death by Medicine

Something is wrong when regulatory agencies pretend that vitamins are dangerous, yet ignore published statistics showing that government-sanctioned medicine is the real hazard.

Until now, Life Extension could cite only isolated statistics to make its case about the dangers of conventional medicine. No one had ever analyzed and combined ALL of the published literature dealing with injuries and deaths caused by government-protected medicine. That has now changed.

A group of researchers meticulously reviewed the statistical evidence and their findings are absolutely shocking.4 These researchers have authored a paper titled "Death by Medicine" that presents compelling evidence that today's system frequently causes more harm than good.

This fully referenced report shows the number of people having in-hospital, adverse reactions to prescribed drugs to be 2.2 million per year. The number of unnecessary antibiotics prescribed annually for viral infections is 20 million per year. The number of unnecessary medical and surgical procedures performed annually is 7.5 million per year. The number of people exposed to unnecessary hospitalization annually is 8.9 million per year.

The most stunning statistic, however, is that the total number of deaths caused by conventional medicine is an astounding 783,936 per year. It is now evident that the American medical system is the leading cause of death and injury in the US. (By contrast, the number of deaths attributable to heart disease in 2001 was 699,697, while the number of deaths attributable to cancer was 553,251.5)

We had intended to publish the entire text of "Death By Medicine" in this month's issue. The article uncovered so many problems with conventional medicine however, that it became too long to fit within these pages. We have instead put it on our website (www.lef.org).

We placed this article on our website to memorialize the failure of the American medical system. By exposing these gruesome statistics in painstaking detail, we provide a basis for competent and compassionate medical professionals to recognize the inadequacies of today's system and at least attempt to institute meaningful reforms.

LE Magazine March 2004

Death by Medicine
By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD

Natural medicine is under siege, as pharmaceutical company lobbyists urge lawmakers to deprive Americans of the benefits of dietary supplements. Drug-company front groups have launched slanderous media campaigns to discredit the value of healthy lifestyles. The FDA continues to interfere with those who offer natural products that compete with prescription drugs.

These attacks against natural medicine obscure a lethal problem that until now was buried in thousands of pages of scientific text. In response to these baseless challenges to natural medicine, the Nutrition Institute of America commissioned an independent review of the quality of "government-approved" medicine. The startling findings from this meticulous study indicate that conventional medicine is "the leading cause of death" in the United States.

The Nutrition Institute of America is a nonprofit organization that has sponsored independent research for the past 30 years. To support its bold claim that conventional medicine is America's number-one killer, the Nutritional Institute of America mandated that every "count" in this "indictment" of US medicine be validated by published, peer-reviewed scientific studies.

What you are about to read is a stunning compilation of facts that documents that those who seek to abolish consumer access to natural therapies are misleading the public. Over 700,000 Americans die each year at the hands of government-sanctioned medicine, while the FDA and other government agencies pretend to protect the public by harassing those who offer safe alternatives.

A definitive review of medical peer-reviewed journals and government health statistics shows that American medicine frequently causes more harm than good.

Each year approximately 2.2 million US hospital patients experience adverse drug reactions (ADRs) to prescribed medications.(1) In 1995, Dr. Richard Besser of the federal Centers for Disease Control and Prevention (CDC) estimated the number of unnecessary antibiotics prescribed annually for viral infections to be 20 million; in 2003, Dr. Besser spoke in terms of tens of millions of unnecessary antibiotics prescribed annually.(2, 2a) Approximately 7.5 million unnecessary medical and surgical procedures are performed annually in the US,(3) while approximately 8.9 million Americans are hospitalized unnecessarily.(4)

As shown in the following table, the estimated total number of iatrogenic deaths--that is, deaths induced inadvertently by a physician or surgeon or by medical treatment or diagnostic procedures-- in the US annually is 783,936. It is evident that the American medical system is itself the leading cause of death and injury in the US. By comparison, approximately 699,697 Americans died of heart in 2001, while 553,251 died of cancer.(5)

Table 1: Estimated Annual Mortality and Economic Cost of Medical Intervention

Condition

Deaths

Cost

Author



Adverse Drug Reactions

106,000

$12 billion

Lazarou(1), Suh (49)



Medical error

98,000

LE Magazine March 2004



Death by Medicine
By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD

THE FIRST IATROGENIC STUDY

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).(16) He found 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, (16a) 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 U.S. 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.

In trying to determine why there are so many medical errors, 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."(23)

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.(14)

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.(16) 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.

ONLY A FRACTION OF MEDICAL ERRORS ARE REPORTED

In 1994, Leape said he was well aware that medical errors were not being reported.(16) 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,

LE Magazine March 2004



Death by Medicine
By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD

What constitutes the "best care"? The CDC does not elaborate and ignores the latest research on the dozens of nutraceuticals that have been scientifically proven to treat viral infections and boost immune-system function. Will doctors recommend vitamin C, echinacea, elderberry, vitamin A, zinc, or homeopathic oscillococcinum? Probably not. The CDC's common-sense recommendations that most people follow anyway include getting proper rest, drinking plenty of fluids, and using a humidifier.

The pharmaceutical industry claims it supports limiting the use of antibiotics. The drug company Bayer sponsors a program called "Operation Clean Hands" through an organization called LIBRA.(57) The CDC also is involved in trying to minimize antibiotic resistance, but nowhere in its publications is there any reference to the role of nutraceuticals in boosting the immune system, nor to the thousands of journal articles that support this approach. This tunnel vision and refusal to recommend the available non-drug alternatives is unfortunate when the CDC is desperately trying to curb the overuse of antibiotics.

Drugs Pollute Our Water Supply

We have reached the point of saturation with prescription drugs. Every body of water tested contains measurable drug residues. The tons of antibiotics used in animal farming, which run off into the water table and surrounding bodies of water, are conferring antibiotic resistance to germs in sewage, and these germs also are found in our water supply. Flushed down our toilets are tons of drugs and drug metabolites that also find their way into our water supply. We have no way to know the long-term health consequences of ingesting a mixture of drugs and drug-breakdown products. These drugs represent another level of iatrogenic disease that we are unable to completely measure.(58-67)

Specific Drug Iatrogenesis: NSAIDs

It's not just the US that is plagued by iatrogenesis. A survey of more than 1,000 French general practitioners (GPs) tested their basic pharmacological knowledge and practice in prescribing NSAIDs, which rank first among commonly prescribed drugs for serious adverse reactions. The study results suggest that GPs do not have adequate knowledge of these drugs and are unable to effectively manage adverse reactions.(68)

A cross-sectional survey of 125 patients attending specialty pain clinics in South London found that possible iatrogenic factors such as "over-investigation, inappropriate information, and advice given to patients as well as misdiagnosis, over-treatment, and inappropriate prescription of medication were common."(69)

Specific Drug Iatrogenesis: Cancer Chemotherapy

In 1989, German biostatistician Ulrich Abel, PhD, wrote a monograph entitled "Chemotherapy of Advanced Epithelial Cancer." It was later published in shorter form in a peer-reviewed medical journal.(70) Abel presented a comprehensive analysis of clinical trials and publications representing over 3,000 articles examining the value of cytotoxic chemotherapy on advanced epithelial cancer. Epithelial cancer is the type of cancer with which we are most familiar, arising from epithelium found in the lining of body organs such as the breast, prostate, lung, stomach, and bowel. From these sites, cancer usually infiltrates adjacent tissue and spreads to the bone, liver, lung, or brain. With his exhaustive review, Abel concluded there is no direct evidence that chemotherapy prolongs survival in patients with advanced carcinoma; in small-cell lung cancer and perhaps ovarian cancer, the therapeutic benefit is only slight. According to Abel, "Many oncologists take it for granted that response to therapy prolongs survival, an opinion which is based on a fallacy and which is not supported by clinical studies."

Over a decade after Abel's exhaustive review of chemotherapy, there seems no decrease in its use for advanced carcinoma. For example, when conventional chemotherapy and radiation have not worked to prevent metastases in breast cancer, high-dose chemotherapy (HDC) along with stem-cell transplant (SCT) is the treatment of choice. In March 2000, however, results from the largest multi-center randomized controlled trial conducted thus far showed that, compared to a prolonged course of monthly conventional-dose chemotherapy, HDC and SCT were of no benefit, (71) with even a slightly lower survival rate for the HDC/SCT group. Serious adverse effects occurred more often in the HDC group than the standard-dose group. One treatment-related death (within 100 days of therapy) was recorded in the HDC group, but none was recorded in the conventional chemotherapy group. The women in this trial were highly selected as having the best chance to respond.

Unfortunately, no all-encompassing follow-up study such as Dr. Abel's exists to indicate whether there has been any improvement in cancer-survival statistics since 1989. In fact, research should be conducted to determine whether chemotherapy itself is responsible for secondary cancers instead of progression of the original disease. We continue to question why well-researched alternative cancer treatments are not used.

Drug Companies Fined

Periodically, the FDA fines a drug manufacturer when its abuses are too glaring and impossible to cover up. In May 2002, The Washington

LE Magazine March 2004



Death by Medicine
By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD

Cesarean Section

In 1983, 809,000 cesarean sections (21% of live births) were performed in the US, making it the nation's most common obstetric-gynecologic (OB/GYN) surgical procedure. The second most common OB/GYN operation was hysterectomy (673,000), followed by diagnostic dilation and curettage of the uterus (632,000). In 1983, OB/GYN procedures represented 23% of all surgery completed in the US. (104)

In 2001, cesarean section is still the most common OB/GYN surgical procedure. Approximately 4 million births occur annually, with 24% (960,000) delivered by cesarean section. In the Netherlands, only 8% of births are delivered by cesarean section. This suggests 640,000 unnecessary cesarean sections--entailing three to four times higher mortality and 20 times greater morbidity than vaginal delivery(105)--are performed annually in the US.

The US cesarean rate rose from just 4.5% in 1965 to 24.1% in 1986. Sakala contends that an "uncontrolled pandemic of medically unnecessary cesarean births is occurring."(106) VanHam reported a cesarean section postpartum hemorrhage rate of 7%, a hematoma formation rate of 3.5%, a urinary tract infection rate of 3%, and a combined postoperative morbidity rate of 35.7% in a high-risk population undergoing cesarean section. (107)

NEVER ENOUGH STUDIES

Scientists claimed there were never enough studies revealing the dangers of DDT and other dangerous pesticides to ban them. They also used this argument for 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 the results of tobacco research. In 1964, when the Surgeon General's report condemned smoking, the AMA refused to endorse it, claiming a need for more research. What they really wanted was more money, which they received from a consortium of tobacco companies that 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 advertisements for Chesterfield cigarettes that claimed 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 more studies are needed before they will support restricting the inordinate use of drugs.

ADVERSE DRUG REACTIONS

The Lazarou study(1) analyzed records for prescribed medications for 33 million US hospital admissions in 1994. It discovered 2.2 million serious injuries due to prescribed drugs; 2.1% of inpatients 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 inpatients and 0.13% of admissions. The authors estimated that 106,000 deaths occur annually due to adverse drug reactions.

Using a cost analysis from a 2000 study in which the increase in hospitalization costs per patient suffering an adverse drug reaction was $5,483, costs for the Lazarou study's 2.2 million patients with serious drug reactions amounted to $12 billion. (1,49)

Serious adverse drug reactions commonly emerge after FDA approval of the drugs involved. The safety of new agents cannot be known with certainty until a drug has been on the market for many years. (110)

BEDSORES

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

LE Magazine March 2004



Death by Medicine (Appendix)
By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD

OFFICE OF TECHNOLOGY ASSESSMENT (OTA)

Health Care Technology and Its Assessment in Eight Countries, 1995.

General Facts

§ In 1990, US life expectancy was 71.8 years for men and 78.8 years for women, among the lowest rates in the developed countries.

§ The 1990 US infant mortality rate in the US was 9.2 per 1,000 live births, in the bottom half of the distribution among all developed countries.

§ Health status is correlated with socioeconomic status.

§ Health care is not universal.

§ Health care is based on the free market system with no fixed budget or limitations on expansion.

§ Health care accounts for 14% of the US GNP ($800 billion in 1993).

§ The federal government does no central planning, though it is the major purchaser of health care for older people and some poor people.

§ Americans are less satisfied with their health care system than people in other developed countries.

§ US medicine specializes in expensive medical technology; some large US cities have more magnetic resonance image (MRI) scanners than most countries.

§ Huge public and private investments in medical research and pharmaceutical development drive this "technological arms race."

§ Any efforts to restrain technological developments in health care are opposed by policymakers concerned about negative impacts on medical-technology industries.

Hospitals

§ In 1990, the US had 5,480 acute-care hospitals, 880 specialty (psychiatric, long-term care, and rehabilitation) hospitals, and 340 federal (military, veterans, and Native American) hospitals, or 2.7 hospitals per 100,000 population.

§ In 1990, the average length of stay for 33 million admissions was 9.2 days. The bed occupancy rate was 66%. Lengths of stay were shorter and admission rates lower than other countries.

§ In 1990, the US had 615,000 physicians, or 2.4 per 1,000 population; 33% were primary care (family medicine, internal medicine, and pediatrics) and 67% were specialists.

§ In 1991, government-run health care spending totaled $81 billion.

§ Total US health care spending rose to $752 billion in 1991 from $70 billion in 1950. Spending grew five-fold per capita.

§ Reasons for increased healthcare spending include:

§ The high cost of defensive medicine, with an escalation in services solely to avoid malpractice litigation.

§ US health care based on defensive medicine costs nearly $45 billion per year, or about 5% of total health care spending, according to one source.

§ The availability and use of new medical technologies have contributed the most to increased health care spending, argue many analysts. These costs are impossible to quantify.

§ The reasons government attempts to control health care costs have failed include:

References

§ Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA . 1998 Apr 15;279(15):1200-5.

§ Rabin R. Caution about overuse of antibiotics. Newsday . September 18, 2003 .
2a. Centers for Disease Control and Prevention. CDC antimicrobial resistance and antibiotic resistance--general information. Available at: http://www.cdc.gov/drugresistance/community/. Accessed December 13, 2003 .

§ For calculations detail, see "Unnecessary Surgery." Sources: HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville , MD. Available at: http://www.ahrq.gov/data/hcup/hcupnet.htm . Accessed December 18, 2003 . US Congressional House Subcommittee Oversight Investigation. Cost and Quality of Health Care: Unnecessary Surgery . Washington , DC : Government Printing Office;1976. Cited in: McClelland GB, Foundation for Chiropractic Education and Research. Testimony to the Department of Veterans Affairs' Chiropractic Advisory Committee. March 25, 2003 .

§ For calculations detail, see "Unnecessary Hospitalization." Sources: HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville , MD. Available at: http://www.ahrq.gov/data/hcup/hcupnet.htm . Accessed December 18, 2003 . Siu AL, Sonnenberg FA, Manning WG, et al. Inappropriate use of hospitals in a randomized trial of health insurance plans. N Engl J Med . 1986 Nov 13;315(20):1259-66. Siu AL, Manning WG, Benjamin B. Patient, provider and hospital characteristics associated with inappropriate hospitalization. Am J Public Health . 1990 Oct;80(10):1253-6. Eriksen BO, Kristiansen IS, Nord E, et al. The cost of inappropriate admissions: a study of health benefits and resource utilization in a department of internal medicine. J Intern Med . 1999 Oct;246(4):379-87.

§ U.S. National Center for Health Statistics. National Vital Statistics Report, vol. 51, no. 5, March 14, 2003 .

§ Thomas, EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care. 2000 Mar;38(3):261-71. Thomas, EJ, Studdert DM, Newhouse JP, et al. Costs of medical injuries in Utah and Colorado . Inquiry . 1999 Fall;36(3):255-64. [Two references.]

§ Xakellis GC, Frantz R, Lewis A. Cost of pressure ulcer prevention in long-term care. Am Geriatr Soc . 1995 May;43(5):496-501.

§ Barczak CA, Barnett RI, Childs EJ, Bosley LM. Fourth national pressure ulcer prevalence survey. Adv Wound Care . 1997 Jul-Aug;10(4):18-26.

§ Weinstein RA. Nosocomial Infection Update. Emerg Infect Dis . 1998 Jul-Sep;4(3):416-20.

§ Fourth Decennial International Conference on Nosocomial and Healthcare-Associated Infections. Morbidity and Mortality Weekly Report. February 25, 2000 , Vol. 49, No. 7, p.138.

§ Burger SG, Kayser-Jones J, Bell JP. Malnutrition and dehydration in nursing homes: key issues in prevention and treatment. National Citizens' Coalition for Nursing Home Reform. June 2000. Available at: http://www.cmwf.org/programs/elders/burger_mal_386.asp. Accessed December 13, 2003 .

§ Starfield B. Is US health really the best in the world? JAMA . 2000 Jul 26;284(4):483-5. Starfield B. Deficiencies in US medical care. JAMA . 2000 Nov 1;284(17):2184-5.

§ HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville , MD. Available at: http://www.ahrq.gov/data/hcup/hcupnet.htm . Accessed December 18, 2003 .

§ Nationwide poll on patient safety: 100 million Americans see medical mistakes directly touching them [press release]. McLean , VA : National Patient Safety Foundation; October 9, 1997 .

§ The Society of Actuaries Health Benefit Systems Practice Advancement Committee. The Troubled Healthcare System in the US . September 13, 2003 . Available at: http://www.soa.org/sections/troubled_healthcare.pdf. Accessed December 18, 2003 .

§ Leape LL. Error in medicine. JAMA . 1994 Dec 21;272(23):1851-7.

§ a.Brennan TA, Leape LL, Laird NM , et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med . 1991 Feb 7;324(6):370-6.

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