The Uninsured:Keep Them That Way – It’s Safer

National Congress on the Un and UnderinsuredDecember 11, 2007

Edward T. Gluckmann, M.S.President, Health Matters, Inc.

20/200 Visionaryhealthmatters@delhitel.net

The opinions expressed are those of Mr. Gluckmann

The Uninsured: Keep Them That Way – It’s Safer National Congress On the Un and Underinsured

Table of Contents

Introduction-Solutions Some Tables on Costs and Medical Care Received MCR Impact Infections Impact Cancer Death Rates, Deaths and Survivals Two Consumer Revolutions, One Women, One Men Pillow Talk: A Foot Note On Aging Impact Alzheimer’s Research On Research How We Treat Those Who Treat Our Most Ill Stents, Devises Florida, Land Of Opportunity Different Visions Myths Deconstructed Can You Play This Game? Does He Or Does He Not? Political Ploys Cancer: First and Last Word Q & A Anybody?

• Solutions-change the thinking• Solutions-eliminate profit and advertising• Solutions-establish independent body-a public trust that

approves only what can be platinum standard validated• Solutions-convert the word medical in any title, activity or

name to wellness and then make its parts comport to that goal

• Compensation is based on action to prevent first and treat later

• Criminalize all activity that benefits an individual, institution or entity that is or appears as a conflict

• Make them wash their hands• Create a National Wellness Service

“Best Health Care System in the World”

• “Today, the United States is undergoing a significant change in the language of medicine.

• “Words that once were said about the health care system reflexively, used to be assumed, increasingly cannot be said in public, or if uttered have to be seriously qualified.

• Unlike Carlin’s words, it is not that words about health care are profane or offensive, it is that they are increasingly untenable and unbelievable.

• Saying them suggests the speaker is out of touch with reality; they are the equivalent of former President George H. W. Bush’s shock at the supermarket checkout scanner.(5)

• They are a sign that the speaker fails to appreciate the experiences of the average American who interacts with the health care system.”

JAMA, V. 297, No. 19, 2131-33,May 16, 2007—Ezekiel J. Emanuel, MD, PhD, (Department of Clinical Bioethics, The Clinical Center, National Institutes of Health), Note: Author’s references numbers are in (..). Italic are mine for emphasis. Bold is quote from another source.

“Best Health Care System in the World”

The statistics are “damning” The system a “mess”

Country Per Capita ($) % of GNP USA 6,000 16.0 Switzerland 4,077 11.5 Norway 3,966 9.7 Germany 3,043 10.6 S. Korea 1,149 8.2

USA Ranking Life Expectancy 45th (behind Bosnia) Infant Mortality Rates (Per 1,000 live births) All 6.37 (behind Cuba) White 5.7 (two times the rate of Singapore/Sweden/Japan)

What Cannot be Said on Television About Health Care, JAMA, V. 297, No. 19, 2131-33, Ezekiel J. Emanuel, MD, PhD, (Department of Clinical Bioethics, The Clinical Center, National Institutes of Health) Author’s reference numbers are in (..).

Number of Americans With Coverage By Type

Type Level of Insurance (000,000) Total Full Under Un

Med/Hosp/Drug 300 30 50 220

Dental 300 30 140 130

Health/Wellness 300 30 10 260

Americans Rate Medical Care Received

California HMOs

Meets National Member

Care Standards Rating

55% 63%

Based on reports for nine top HMOs that

cover 90% of HMO covered population in CA

State of California Website 10/2007

Comparison of Selected Benchmarks Before/After Expanded Insurance

Before After . Total Cost $2,200,000,000,000 $2,604,000,000,000* Cost Per Insured $7,333 - $8,800** $8,000 - $9,600 GDP % 16% -18%* 20% - 22% Quality Rating*** 37th - 45th 37th - 45th

Waste**** 20% - 70% 35% - 75% Deaths Due to Care***** 449,000 - 1,000,000 529,000 - 1,080,000

* Add $50 billion to cover price increases and correction of estimated costs. ** Depends on who is doing the count. But who is? Everyone! *** USA compared to the world for selected benchmarks. **** Estimated based on various indicators of waste. ***** Used conservative 80,000 additional deaths due to medical care received (MCR)

Standard Leading Cause of American Death Rankings

Rank/Cause Deaths (#) %/Total Death Rate All causes . . . . . . . . 2,443,387 100.0 847.31 1 Diseases of heart . . 696,947 28.5 241.72 2 Malignant neoplasms . 557,271 22.8 193.23 3 Cerebrovascular diseases . . . . . . 162,672 6.7 56.44 4 Chronic lower respiratory diseases. 124,816 5.1 43.35 5 Accidents (unintentional injuries) . 106,742 4.4 37.06 6 Diabetes mellitus . . . . . . . . . . 73,249 3.0 25.47 7 Influenza and pneumonia . . . . . . 65,681 2.7 22.88 8 Alzheimer’s disease. . . . . . . . . . . 58,866 2.4 20.49 9 Nephritis, nephrotic syndrome and nephrosis . . . 40,974 1.7 14.21 10 Septicemia . . . . . . . . . . . . . . 33,865 1.4 11.70 11 All other causes . . . (Residual) 522,304 21.4 181.10

Leading Cause of American Death Rankings-Another View

Rank/Cause Deaths (#) %/Total Death Rate All causes . . . . . . . . 2,443,387 100.0 847.31 1 MCR (Liberal) 783,936 32.0 2 Diseases of heart . . 696,947 28.5 241.72 3 Malignant neoplasms.. 557,271 22.8 193.20 4 MCR (Conservative) 424,000 17.0 5 Cerebrovascular diseases . . . . 162,672 6.7 56.44 6 Chronic lower respiratory dis. 124,816 5.1 43.35 7 Accidents (unintentional injuries).. 106,742 4.4 37.06 8 Diabetes mellitus . . . . . . . . . . 73,249 3.0 25.47 9 All other causes……………………

A Leading Cause of Death: Medical Care Received (MCR)

ANNUAL PHYSICAL 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 $2 billion IOM(6) Bedsore 115,000 $55 billion Xakellis(7), Barczak(8) Infection 88,000 $5 billion Weinstein(9), MMWR(10) Malnutrition 108,800 -------- Nurses Coalition(11) Outpatients 199,000 $77 billion Starfield(12), Weingart(112) Unnecessary Procedures 37,136 $122 billion HCUP(3,13) Surgery-Related 32,000 $9 billion AHRQ(85)Totals: 783,936 $282 billion or 12.8% of $2.2 trillion

The American Medical System Is The Leading Cause Of Death And Injury In The United States, Gary Null PhD,Carolyn Dean MD ND, Martin Feldman MD, Debora Rasio MD, Dorothy Smith PhD. (..) indicates reference numbers in original

Hospital MCR Deaths Per Year By Type

• 12,000 - Unnecessary surgery• 7,000 - Medication errors • 20,000 - Other errors • 80,000 - Nosocomial infections• 106,000 - No error, adverse effects of medications

Is US Health Really the Best in the World?, JAMA, July 26, 2000—V. 284, No. 4 483-85

Hospital MCR Deaths Per Year

Medical Care Received (MCR)

Caused Deaths Per Year

225,000

Is US Health Really the Best in the World?, JAMA, July 26, 2000, V. 284, No. 4 483-85

Medical Injury Is Significant Threat

“In conclusion, our results clearly show

that medical injuries in hospitals pose

a significant threat to patients and incur

substantial costs to society.”

Excess Length of Stay, Charges, and Mortality Attributable to Medical Injuries During Hospitalization, JAMA,

2003:290: 1868-1874

There is trouble at

the most unlikely of places

An ambulance just arrived at the famous

“Pinata” Hospital

The patient was heard screaming

to the ER Nurse!

“Please hurry, I’m losing my candy.”

Is There An Extra Doctor In the House? “One analysis overcomes some of these limitations by

estimating adverse effects in outpatient care and including adverse effects other than death.[11].

Adverse effects: 4%-18% Extra doc visits: 116,000,000 Extra prescriptions: 77,000,000 Extra ER Visits: 17,000,000 Extra Hospital Admissions: 8,000,000 Extra Long Term Admissions: 3,000,000 Extra Deaths: 199,000 Extra Cost: $77,000,000,000

Is US Health Really the Best in the World?, JAMA.2000; 284: 483-485 Barbara Starfield, MD, MPH, Department of Health Policy and Management, Johns Hopkins School of Hygiene and Public Health. Her reference in article [11] Epidemiology and medical error, Weingart SN, Wilson RM, Gibberd RW, Harrison B.. BMJ. 2000;320:774-777

Just Keep Me From The ER This Time

• 50 million unnecessary annual visits to the ER• 95 per minute• # by the time I finish? • What is the cost? • What is the benefit?

National Center for Health Statistics

Medical Care Received (MCR) Caused Deaths Per Year

Hospital Based Deaths: 225,000 Non-Hospital Based Deaths: 199,000

Total Deaths: 424,000

Is US Health Really the Best in the World?, JAMA, July 26, 2000, V. 284, No. 4 483-85

A Hospital Is No Place To Be Sick Infections Acquired During Hospital Stays Kill More People Than Breast

Cancer, Auto Accidents and AIDS Combined— Reports on the impact of 19,154 reported hospital acquired infections (HAI) in 2005 at 168 hospitals in Pennsylvania

BENCHMARK HAI INVOLVED HAI NOT INVOLVED Average Length of Stay 20.6 (days) 4.5 (days) Extra Days 396,129 - 0 - Extra Hospital Charges $3.5 billion - 0 - Average Hospital Charges $185,260 $31,289 Hospital Patients Who Died 12.9% 2.3%

This report recommends that everyone wash their hands! Other reports suggest that patients have friends stay with them in the

hospital to protect them from human errors and complacency!

Hospital-acquired Infections in Pennsylvania, Pennsylvania Health Care Cost Containment Council, November 2006, Data Reporting Period: January 1, 2005 - December 31, 2005, Pennsylvania Health Care Cost Containment Council, November 2006

A Hospital Is Just A Taxi With The Meter Running

The . Excess . Event LOS Charges Mortality*Surgical Care Post-op Sepsis 10.89 $57,727 21.96%

Dehiscence 9.42 $40,323 9.63% Medical Care Infection 9.58 $38,656 4.31%*Attributable Excess Length of Stay, Charges, and Mortality Attributable to Medical Injuries During Hospitalization, JAMA, 2003: 290: 1868-1874

Rising Resistance Rising

• S. aureus (staph) 32% vs. methicillin • S. aureus (staph) 98% vs. penicillin• E. faecium 70% vs. cirpofloxian/ampicillin• S. pneumoniae (strep) 37% vs. penicillin

Everyday exposure to toxic pollutants, Scientific American, Feb/March 1998: 86-91

Staph Infections: Life Threatening• CC/Symptoms: 94,000 MRSA Infections 19,000 MRSA Deaths • Risk Factors: Most MRSA associated with health care Unnecessary, recent or long-term prescribing of antibiotics Antibiotics in food and water* Current or recent hospitalization or residing in a long-term care facility Invasive procedures/Bacterial mutations • History: They do not wash their hands Takes time to wash Time is money No incentive to wash More illness, more income• Diagnosis: Dirty Hands • Treatment: Wash Hands• Prognosis: Uncertain *Medical Drugs Pollute Water Supply, Maria P. Elliott and Edward T. Gluckmann, Green Times, V.27, No. 3, 2007 Pages 11-12 CDC Report, JAMA and New York Times, Infection Control Today, October 16, 2007

Two Views: Professional Practice Of Medicine

I recently went to a new doctor and noticed he was located in something called the Professional Building. I felt better right away. 

Isn’t it a bit unnerving that doctors call what they do “practice”? George Carlin

Program to Get Them to Wash Their Hands

Teach hand washing (Medical School and Residency) Put hand washing questions on all board exams (Competency) Add to credentialing process (Washes hands: Often? Vigorously?) Have soap companies fund research and CME (Reduce costs) Develop a new CPT code (P4P, Positive Incentive) Report failure to wash to Homeland Security (Be Alert and Report!) Rate all providers who fail to wash hands. (Transparency) Fine providers for failure to wash hands (Negative Incentive) Provide universal insurance for 50,000,000 uninsured Americans? Fail! Hear my mother’s, “Edward, wash your hands.” over intercom.” (Equivalent of legal water-boarding.)

System Failure versus Personal Accountability — The Case for Clean Hands, NEJM, V. 355, No. 2, :121-123, 7/13/2006

Change in the US Death Rates* by Cause, 1950 & 2003

* Age-adjusted to 2000 US standard population.Sources: 1950 Mortality Data - CDC/NCHS, NVSS, Mortality Revised.2003 Mortality Data: US Mortality Public Use Data Tape, 2003, NCHS, Centers for Disease Control and Prevention, 2006

21.9

180.7

48.1

586.8

193.9

53.3

190.1

231.6

0

100

200

300

400

500

600

HeartDiseases

CerebrovascularDiseases

Pneumonia/Influenza

Cancer

1950

2003

Rate Per 100,000

Trends in the Number of Cancer Deaths Among Men and Women, US, 1930-2003

0

50,000

100,000

150,000

200,000

250,000

300,000

1930 1940 1950 1960 1970 1980 1990 2000

Women

Men

Nu

mb

er o

f C

ance

r D

eath

s

265,000

270,000

275,000

280,000

285,000

290,000

2000 2001 2002 2003

Men

Women

Source: US Mortality Public Use Data Tape, 2003, National Center for Health Statistics, Centers for Disease Control and Prevention, 2006.

Five-year Relative Survival (%)* During Three Time Periods By Cancer Site

*5-year relative survival rates based on follow up of patients through 2002. †Recent changes in classification of ovarian cancer have affected 1995-2001 survival rates.Source: Surveillance, Epidemiology, and End Results Program, 1975-2002, Division of Cancer Control andPopulation Sciences, National Cancer Institute, 2005.

 

 

 

Site 1974-1976 1983-1985 1995-2001• All sites 50 53 65• Breast (female) 75 78 88• Colon 50 58 64• Leukemia 34 41 48• Lung and bronchus 12 14 15• Melanoma 80 85 92• Non-Hodgkin lymphoma 47 54 60• Ovary 37 41 45• Pancreas 3 3 5• Prostate 67 75 100• Rectum 49 55 65• Urinary bladder 73 78 82

†

Another Warrior Fights Cancer

• 'Her determination to fight the disease is an inspiration to all of us.’ …President Bush

• 'I always admired Congresswoman … strong convictions and the tenacity..’ John W. Warner

• She underwent chemotherapy treatments and a mastectomy…in 2005. When the cancer returned, she underwent chemotherapy again...

• ..she died...after a 2-year battle with the disease.

Congresswoman Dies After Cancer Fight, New York Times, October 10, 2007

Women’s Revolution

•HRT associated with cancer, heart disease and stroke in media•Millions of women stopped following physician orders•Millions stopped hormone replacement therapy (HRT) •14,000 fewer new cases in 2003•7% decline in breast cancer between 2002 and 2003•“It takes breast cancer a long time to develop…” •“..but here we are primarily talking about existing cancers that are fueled by hormones and that slow or stop their growing when a source of fuel is cut.“•"It is the largest single drop in breast cancer incidence within a single year..” Fewer breast cancers linked to less hormone therapy, Reuters, December 14, 2006 Findings reported by MD Anderson based researchers at the 29th Annual San Antonio Breast Cancer Symposium

Lung Cancer - Black Revolution

• Lower rate of lung cancer surgery among black patients due partly to communication problems, study finds

• Even with equal access, blacks are about half as likely as whites to undergo surgery that could save their lives

• Black men have higher death rates than white men for lung cancer

• Smoking explains virtually all the disparity between black men and white men in cancer mortality rates

Dana-Farber Cancer Institute, Website, Christopher Lathan, MD, Spring/Summer 2006

Lung Cancer - Black Revolution

• Death rates for black men went up as smoking increased

• Smoking among black men peaked in 1990• CDC has registered sharp declines in black men

smoking since 2001 • When smoking declined: cancer rates dropped• 1990 - 2000, the mortality rate dropped 11%

• If black men stopped smoking, their cancer rates

would drop 66% Lung cancer rates as an index of tobacco smoke exposures: validation against

black male non- lung cancer death rates, 1969-2000, Prev Med. 38(5):511-15

Cancer Care More Aggressive Near Death: Study

• Doctors efforts are costly, futile attempt to extend lives • Chemo up 6% • Chemo up 34% in patients who died within two weeks• Doctors should review their treatment regimens• Doctors should in some cases focus on palliative care• Hospice care reduces aggressive treatment; improves

quality of life for terminally ill Study suggests more cancer patients receiving aggressive care at end-of-life, Dan-Farber Cancer Institute, June 4, 2003

Annualized Cost To Buy 20 Days

• $143,612 - Localized Cancer • $145,861 - Regional Cancer• $1,190,322 - Metastatic Cancer • 70%-90% of lung cancer smoking related• Smoking prevention and cessation programs are more

promising

Survival Benefit Minimal Despite Rising Cost of Lung Cancer Treatment in Elderly, Cancer, 2007 (reported in) MedScape Medical News, October 25, 2007

Sleep On This For A While

“Poor sleep among the elderly, it turns out,

is not because of aging itself, but mostly

because of illnesses or the medications

used to treat them.”

The Elderly Always Sleep Worse, and Other Myths of Aging, NY Times, October 23, 2007

Dark Blue Is Medical Cost Increases Due To Aging!

Early Detection, Survival and Marketing

• Claims made:

-Cancer survival rates increased

-2.3 million breast cancer survivors • SCR: Best Cancer Treatment (Surgery,

Chemo, Radiation)

New Ventures Help Fight the Frustrations of Fighting Breast Cancer, New York Times, October 25, 2007

Early Detection, Survival and Advertising

Disfigurement/Pain/Realism/Death

• Cancer as bad as it is, emotionally had an end• Lymphedema complication, forever affects quality of life +++++++++++++++++++++++++++++++++++++++++++• Optimistic survivors also realists • Since their book was published, 2 of 3 co-authors died

New Ventures Help Fight the Frustrations of Fighting Breast Cancer, New York

Times, October 25, 2007

Early Detection, Survival and Sales • Drive to find disease early that leads to..• Diagnostic epidemic that leads to.. • Medicalization of everyday life that leads to..• 50% of Americans diagnosed as diseased that leads to..• More disease caused by tests, treatment and drugs that leads to..• Threat to Americans health that leads to.. • America spends more than any other country that leads to..• America having: (Please check all that apply) ___ The best care in the world ___ A need to stop the hemorrhaging first ___ Some of the lowest world wide rankings ___ A need to spend an additional $300,000,000,000 What’s Making Us Sick Is an Epidemic of Diagnoses, New York Times, January 2, 2007

Early Detection, Survival and Collection • 40% of summer camp kids on chronic prescription drugs• Arthritis without joint pain• Stomach damage without heartburn• Million prostate cancers patients who have lived as long

without being diagnosed as a cancer patient• Biggest health threat is our health-care system • Pre-diseased population > those who get the disease• Labeling causes anxiety, sense of vulnerability …a particular concern in children

What’s Making Us Sick Is an Epidemic of Diagnoses, New York Times, January 2, 2007

Early Detection, Survival and Impact on Children

• Psychiatrists in several states get most drug money• Psychiatrists who do take the money, tend to prescribe

the most antipsychotic drugs to children• These drugs are risky and not FDA approved for kids

• Psychiatrists know the dangers

• Antipsychotic drugs are a large expense for Medicaid Psychiatrists Top List in Drug Maker Gifts, New York Times, June 27, 2007

Early Detection, Survival and Causes of Disease

• Assumption is all diagnosis are beneficial. • Early Detection = Prevention = Threat• But at the extreme, the logic of early detection is absurd• Biggest health threat is our health-care system • Pre-diseased population > those who get the disease• Labeling causes anxiety, sense of vulnerability …a particular concern in children

What’s Making Us Sick Is an Epidemic of Diagnoses, New York Times, January 2, 2007

Early Detection, Survival, Harm

• Disease epidemic = Treatment epidemic• Not all treatments have important benefits • Some involve potential harm• Some harm is not immediately known• Being labeled “pre-diseased” or “at risk” but destined to

remain healthy, treatment can only cause harm.

What’s Making Us Sick Is an Epidemic of Diagnoses, New York Times, January 2, 2007

Early Detection, Survival: Good 4 Business! Bad 4 Business?

The epidemic of diagnoses has many causes. More diagnoses mean more money, stature for: - Drug and device manufacturers - Hospitals and physicians, - Disease-based advocacy organizations - Researchers - National Institutes of Health - Anyone promoting a disease

What’s Making Us Sick Is an Epidemic of Diagnoses, New York Times, January 2, 2007

Where’s Proof Treatment Works, Works Safely • Gold Standard-randomized double blind,

placebo-controlled trials.• Platinum Standard-monitor actual outcomes for

all patients for 1,3,5,7,10 years.• How many physicians, surgeons or hospitals can

produce cost/benefit data (i.e. positive and negative outcomes vs. charges/fees)?

• Without the proof there is information, value or

meaningful use by consumers!

Off-Label Prescribing: Thar’s AU, But No Standard, In Them Thar Hills Summary of Number of Drug Uses, By Off-label Status and Level of

Supporting Evidence, United States, July 2005 through December 2006, IMS Health National Therapeutic and Disease Index, Estimated DRUG USES IN THOUSANDS, United States

Generic Total Uncertain/ Evidence Evidence

On-Label Off-Label Inadequate Inadequate Uncertain 112,033 42,692 37,387 7,380 30,007 72%* 28%* 87%** 17%** 70%**

* % of total prescriptions = generic on-label + total off-label; ** % of total that are off-label; 5,305,000 or 12% off-label prescriptions were deemed OK. Off-Label Drug Use, Stanford School of Medicine, Stanford Prevention Research Center, Randall Stafford, MD, PhD., Week of 06/04/2007

$3,430 Billion Reasons Explain Rising Costs Mo./Year Company/Drug/Disease Allegations Settlement9/2007 Sanofi-Aventis Violated False $190 /Anzemet/Cancer Claims Act Inflated Prices/Physicians Profits, Medicare/Medicaid9/2007 Bristol Meyers Squibb/ Illegally Promoted $515 Abilify/Anti-psychotic use for Off-label Drug Use-Pediatric/ Dementia By Consulting Fees/Luxury Trips 9/2007 Zommer, Biomet Kickbacks/Surgeons $311 DePuy Orthopaedics (J&J) Smith & Nephew/ Replacement Hips & Knees2006 Medtronics Consulting Fees/Free $ 40 Spinal Implants Travel/Other Perks2007 Again Accused of Similar Charges-not Settled (yet)2007 Purdue Frederick/ Misbranding/Misleading $634* OxyContin/Pain Killer Information re: Addictive Characteristics2007 Schering Sales Corp./ Lied to Gov’t re: Pricing/ $435 and Parent Company/ Illegal Promotion for Temodat & Intron A/ Off-label Use-Cancers Glioblastoma multiforme2004 Pfizer Inc./Neurontin Off–label Use for $430 Epilepsy Pain and Psychiatric Illness2001 Tap Pharmaceutical Inflation of Prices $875 Products/Lupron/ Bribed Physicians Prostrate CancerAll figures (000,000) September: A Banner Month For Drug Industry Crime, NewsTarget.com

When asked why he robbed banks, Willy Sutton said “That’s Where the Money Is”

Willie was wrong! Willie would not find $3,430,000,000

in most banks.

This is the tip of the iceberg.

Nothing went to any victim. No part of these settlements went to

improve patient safety.No physician was: reported, disciplined charged with accepting bribes, compromising patient care or censured for reflecting poorly on

the profession.

$4.85 Billion Settlement Is Victory For Drug Company

• 2001 JAMA article warns of Vioxx risks• 9/2002: Vioxx increased risk of heart attacks/strokes • Merck spends more than $1.2 billion on Vioxx-related legal fees• 9/2004 Vioxx withdrawn by Merck• 8/2005: First verdict: $253,500,000 (Reduced to less than $25,000,000)

• 2006/2007, Merck defeats 8 of 10 plaintiffs in CA, FL, NJ, IL, LA • 11/2007 Merck settles 27,000 Vioxx suits for $4.85 billion• Settlement = 9 months profits • Wall Street reacted favorably • Merck still facing civil and criminal action by several states and feds

Merck Agrees to Settle Vioxx Suits for $4.85 Billion, New York Times, November 9, 2007 Analysts See Merck Victory in Vioxx Settlement, New York Times, November 10, 2007

Regrettable Human Error

September 2006• F.D.A. reconvenes safety panel and OKs continued use of drug• Company study showing adverse impact of drug not revealed to F.D.A.• Company says failure to report findings was due to: Click here to return to RegretsOctober 2007• Researchers stopped a study of drug because 50% more likely to die vs. alternatives Drug increased the risks of kidney failure, heart attack and stroke Causes 10,000 to 11,000 kidney failures a year (Click here to return to Regrets) Stop and save more than $1 billion a year in dialysis costsNovember 2007 • Bayer AG announced agreed to withdraw its controversial heart surgery drug • F.D.A. could not identify any population where the benefits outweigh the risks• Bayer says drug is beneficial when used as directed (Click here to return to Regrets)

Heart Surgery Drug Pulled From Market, New York Times, November 6,2007

How Many Errors Were Not Detected?

Non-Hospital Drug Adverse Effects Reported To the FDA in 1998 and 2005

Event 1998 2005 Increase All Drugs Serious, adverse 34,966 89,842 260% Serious, fatal 5,519 15,107 270% 13 new biotech products 580 9,181 1,580% These data show a marked increase in reported deaths and serious injuries

associated with drug therapy over the study period. The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs.

Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005, Arch

Intern Med,  2007;167:1752-1759

A Drug Shark’s Tale

• Lipitor patent runs till 2010• Generic for Zocor, a Lipitor competitor, is now available• Pfizer’s response: Tell Wall Street: Will spend two times more for ads Argue that a non-gold standard study shows value Attack insurers Hire a BIG name, hit man for ads

Maker of Lipitor Digs In to Fight Generic Rival, New York Times, November 3, 2007

Some More Tales• FDA cannot guarantee the safety of the nation's drug supply • Foreign companies manufacture 80% of all ingredients used by

American drug makers• FDA’s records are poor• FDA cannot even say what it inspected F.D.A. Is Unable to Ensure Drugs Are Safe, Panel Is Told, NYT, November 2, 2007

• $20,157 buys a patient less than one month of increased survival• Results are not surprising: “There is no early detection screen of proven worth as yet,.." “There are no good predictors to identify lung cancer at an early

stage,.” “..so you would not expect an increase in early diagnosis to

affect improvement in survival.“ (Stephen Spiro, MD, head, department of thoracic medicine, University College London Hospitals National Health Service Trust, UK)

Survival Benefit Minimal Despite Rising Cost of Lung Cancer Treatment in Elderly, Medscape Medical News, October 25, 2007

Alzheimer’s=Disease=Research=Drugs • Scientists reported progress… blood test…90 percent

accurate in distinguishing …80 percent accurate in predicting…

• Outside experts called the results …promising but preliminary

• At present, treatments for Alzheimer’s disease are not very effective…

• …when drugs are developed that slow or halt …• Alzheimer’s sent out signals to the body’s immune

system…communication between cells • paid for by… and Satoris, a company co-founded…to

commercialize the test. Progress Cited in Alzheimer’s Diagnosis, NY Times, October 15, 2007

Alzheimer’s: Prevention Forgotten

• Not one word about a cure!• Not one word about prevention! • Not one word about what the body is missing!• Not one word about using the cells communications! • Not one word about the role of the immune system! Progress Cited in Alzheimer’s Diagnosis, NY Times, October 15, 2007

Four Red Dots?

Science 313: 670-673 (August 4, 2006)

Research: Finding What Is Known • Place: Rockefeller University’s Leonard Wagner

Laboratory of Molecular Genetics and Immunology • Problem: The IgG paradox! IgG antibodies can prevent

or cause autoimmune disorders (lupus, arthritis, asthma) • Findings: Terminal sialic acid on the Fc portions of the

IgG molecule stopped inflammation• Explanation: IgG can shift from a state that is quite

inflammatory to a state that is actively anti-inflammatory by just changing a sugar

• Solution: Want to develop another drug• Issue: Natural remedy already exists

Science 313: 670-673 (August 4, 2006) Harper’s Biochemistry, 25th Edition, Chapter 56, Page 675, McGraw-Hill, 2000

An Educated Consumer Is Our Best Customer• Once paid $11.60 per month for Blue Cross • In one week, received three pieces of mail: 43 pages about Medicare drug plan options Letter from company: What happens if selected plan is dropped Letter from a politician saying how great drug plan is• Had to research 30 plans to get doctor/hospital, drug

and cost info Times Herald-Record, Letter to Editor, November 8, 2007, Page 27

We Are Rated By How We Treat The Least Among US

• 1974 - 1975 House Staff physicians go on strike at 25 hospitals• Demands include end of abusive work schedules • Demands for more nursing, lab, messenger staff• Most strikes settlements are inconclusive• Some reductions in work hours and temporary staff improvements• 1984 - one patient dies after ER admission at New York Hospital• Grand Jury finds overworked and under supervised house staff• New laws and professional GME guidelines are established• GME groups concerned that training and patient care suffer Intern and Resident Organizations in the United States: 1934-1977, Robert G. Harmon, M.D., The Milbank Memorial Fund Quarterly. Health and

Society, V. 56, No. 4 (Autumn 1978), pp. 500-530, supplemented by the presenter

Even The Pros Have Trouble With Handoffs! Improved patient care conditions are less evident than improved

house staff conditions.(1) But do these benefits mean that today's interns and residents have

it better? Are they learning more? Probably not.(2) In addition to problems with handoffs, house staff are particularly

vulnerable to medical errors owing to teamwork failures, especially lack of supervision. Graduate medical education reform should focus on strengthening these aspects of training…(3)

Serious consequences: 33% or 889 cases resulted in deaths.(4) (1) Intern and Resident Organizations in the United States: 1934-1977, Robert G. Harmon, M.D.,

The Milbank Memorial Fund Quarterly. Health and Society, Vol. 56, No. 4 (Autumn, 1978), pp. 500-530

(2) Do today's medical residents really have it better? Cleveland Clinic Journal of Medicine, Frank Michota, MD

(3) Medical Errors Involving Trainees, A Study of Closed Malpractice Claims From 5 Insurers, Arch Intern Med, 2007;167:2030-2036.

(4) Lack of communication tied to errors: report, Modern Healthcare’s Daily Dose, October 10, 2007

House Staff Training Fatigue Errors

Number of Extended Duration Shifts/Month Event Base/None One-Four Five Reported-Fatigue Related Significant: Medical Error 100% 300% 700% Adverse Event 100% 700% 800% Preventable Adverse Event 100% 100% 300% Interns were also more likely to fall asleep during lectures, rounds, and clinical activities, even

surgery…In our survey, extended-duration work shifts were associated with an increased risk of significant medical errors, adverse events, and attentional failures in interns across the United States. These results have important public policy implications for postgraduate medical education

Impact of Extended-Duration Shifts on Medical Errors, Adverse Events, and Attentional Failures, National Institute for Occupational Safety and Health within the US Centers for Disease Control (Grant R01OH07567) and the Agency for Healthcare Research and Quality (AHRQ) (Grant R01 HS12032)

Stents: Sugar or Diet • No clear comparative evidence studies to show which treatment is best,

best over time, best in terms of disease type, level, and cost and how each treatment compares to other treatments, including prescription drugs, angioplasty alone, by-pass surgery, and changes in nutrition, supplements and other life style modifications. (Edward Gluckmann, Health Matters, Inc.)

• “It’s striking that we do so little to evaluate what we’re getting in return for it,” (CBO Director Peter Orszag)

A Heart Stent Gets a Reprieve From Doctors, New York Times, November 13, 2007; Aging population isn’t the real threat, says CBO, Modern Healthcare’s Daily Dose, November 13, 2007

• “The type of funding may have determinant effects on the design of studies and on the interpretation of findings: funding by the industry is associated with design features less likely to lead to finding statistically significant adverse effects and with a more favorable clinical interpretation of such findings. Disclosure of conflicts of interest should be strengthened for a more balanced opinion on the safety of drugs.”

Adverse Effects of Inhaled Corticosteroids in Funded and Non-funded Studies, Arch Intern Med .  2007;167:2047-2053 For the Record: In Tests of Inhalers, Results May Depend on Who Pays, New York Times, November 13, 2007

Devices, Implants And Either This Guy Is Dead Or My Watch Stopped!

• Nation’s largest maker of implanted heart devices to

docs: stop using a crucial component of our most recent defibrillator models.

• These devises caused malfunctions in hundreds of patients and may have contributed to five deaths.

• 235,000 patients have these devices that can make them misread heart-rhythm data.

• Cost $30,000/device • Cost per year = $7,050,000,000 Patients Warned as Maker Halts Sale of Heart Implant Part, New York Times, October 15, 2007

Florida: Land Of Opportunity

• The wheelchair billed for $5 million• Millions billed by an air conditioning repairman for

specially formulated asthma medication • High level of AIDS billing with no clinical explanation• Criminal entrepreneurship funded by public• Fraud penalties much less severe than they are for

narcotics trafficking

Fraud and Florida's multimillion-dollar wheelchair, Reuters, October 22, 2007

Visions of Medical Care-Ideal • “Group medicine is not a financial arrangement ..“ • “..(do) we take sufficient care to make a thorough physical

examination..?” • “..some loss in appreciation of the individuality of the patient..” • “the main purpose to be served by the Clinic is the care of the sick.“• Operate ..intended not to create wealth but to provide a financial

return sufficient for present and future needs. • 30% of less fortunate patients received hand written bills marked

paid in full. (They weren’t paid. They were just written off!)• No one charged more than 10% of his or her annual income, no

matter how expensive the treatment.• Every dollar on bills over $1,000 went to help other sick people

Mayo Clinic Foundation Website and The Value of Sharing, The Story of the Mayo Brothers, by Spencer Johnson, M.D. (Education includes a psychology degree from the University of Southern California, an M.D. from the Royal College of Surgeons and medical clerkships at Harvard Medical School and the Mayo Clinic)

Visions of Medical Care-Investment Opportunity

HCA buyers got $175 million in fees

The group that bought HCA, will receive $175 million in transaction fees, and other fees down the road. Thomas Frist, Jr., a relative of the former Republican Party (Congressional leader) and members of his family, and top-level HCA executives, will also get $15 million annually under a management contract with HCA, which includes possible increases based on the new company’s profits. The buyout was for $33 billion. Several executives are guaranteed board seats as part of their employment agreements.

Modern Health’s Daily Dose, a daily e-mail report on current healthcare events. The exact date is not crucial. This is a sample of many

such reports that run into the billions nationwide over the course of any year.

Visions of Medical Care-Wellness (First) A Drug Maker’s Views of What Ails American Health Care

Holstein: “What should Americans be doing to fix the system?”

Vasella: “One aspect is better patient education and better

nutrition…we should look at how to give incentives to people to avoid disease-prone behaviors…

Saturday Interview of Daniel L. Vasella, chief executive of Novartis by William Holstein, New York Times, September 8, 2007

Myths Deconstruction

Another way of saying, we are doing nothing to save money. If all these claims actually worked, medical care would be free. Total costs would be going down. They are not.

Maybe for one patient here and there, but not overall. (See above.) Almost without exception, buying and selling (M & A) or just gross

transfers from one investment group to another is a business transaction loaded with costly stock options, profit/loss considerations, market positioning, golden parachutes, lucrative broker and other fees and has nothing to do with improving care or quality.

Putting an investigation or litigation behind without any acceptance of wrong doing is just another way of saying: We got caught (acceptable business risk) with our hands in the cookie jar, and we got away with it (as we thought we would) by buying off prosecution with pennies on the dollar settlement, (another acceptable business cost). Now we can get on to make more money claiming to care about saving lives while agreeing to keep our hands out of the cookie jars, (but just for a while) and making more money.

Myths Deconstruction

Cost shifting is just that, the shifting of costs from the insurer, to the insured and among the insured and underinsured. It costs more not less.

Consumer empowerment started in the 1970’s and failed then. Everyone speaks for the consumer, yet no one really does. Consumers have few choices and options. Most consumers have time to surf the Internet, but few understand the implications of what is going on when told they have cancer, or have had a serious heart attack or experiencing a stroke.

Ditto Alzheimer’s, autism, emotional and mental turmoil. People with diabetes, are overweight, or obese are facing

information that is contradictory, unproven and often not supported in a variety of ways, not least of which, is that the recommendations of what to do and what will be done have no consistent pattern of working. Proof: Look around. Read the statistics. See America’s world comparative rankings.

“DOES ANYBODY HERE KNOW HOW TO PLAY THIS GAME?”

• Health insurance companies cited ..for violation of Medicare standards...(said) they were addressing the deficiencies and would improve service to patients, who will be able to switch plans in the last six weeks of the year.

• ...WellPoint, one of the nation’s largest insurers, said the company had hired additional employees to answer telephones and pay claims filed by or for Medicare beneficiaries..WellPoint was reducing its claims backlog and telephone waiting times and expected to be in compliance with federal standards by the end of this month.

• Coventry Health Care, which recently had a civil penalty of $264,000 assessed for violation of Medicare marketing standards, said it had taken steps to prevent a repetition of the problems.

After Audit, Insurers Vow to Improve Medicare Service, New York Times, 10/10/2007

“DOES ANYBODY HERE KNOW HOW TO PLAY THIS GAME?”

• ..a spokeswoman for Coventry, said the company had retrained its agents and changed the timing of commission payment to discourage inappropriate sales.

• ..(a) public policy director at CareOregon, based in Portland, said her company was “very serious” about correcting deficiencies and was revising its procedures.

• ..CareOregon, which serves low-income people enrolled in both Medicare and Medicaid, questioned the wisdom of one recommendation, involving notices to beneficiaries about the denial of claims. “To send all these notices could confuse and scare our patients,..

After Audit, Insurers Vow to Improve Medicare Service, New York Times, October 10, 2007

“DOES ANYBODY HERE KNOW HOW TO PLAY THIS GAME?” When Dealing With The Insane, It Is Best To Pretend To Be Sane

Senator Max Baucus, Democrat of Montana, chair, Finance Committee:

“The unscrupulous tactics of some plans have led me to be skeptical about how well this market works for seniors.”

And Representative Pete Stark, California Democrat, chair of the Ways and Means Subcommittee on Health: that the Bush administration had been reluctant to “regulate or offend these large companies.”

But Kerry N. Weems, acting administrator of the Centers for Medicare and Medicaid Services: “contract compliance and beneficiary protection” had been among his top priorities since he took office last month.

Karen M. Ignagni, president of America’s Health Insurance Plans said the audits did not reflect the fact that private plans “generally offer better benefits” than original Medicare.”

The answer is yes. They all know how to play this game.

After Audit, Insurers Vow to Improve Medicare Service, New York Times, October 10, 2007

Does He Or Does He Not? • A Senator says his disease had progressed• a very tough disease,” “it could progress rapidly..” “It’s

possible the diagnosis is wrong,” Bruce Miller, Neurologist, UC

• “….tests can monitor the progression of the disease • “In some cases I’ve followed patients for many years…” Norman Relkind, Neurologist, Cornell Medical Center

• And they need regular medical visits to monitor the progression of the disease

• The larger question for society…will be figuring out how and by whom decisions should be made about other people’s mental capacity to work, vote and make choices for themselves. Often, he said, doctors will have to be involved (Dr. Karlawish, Medicine & Medical Ethics, U of P)

Senator’s Illness Requires Monitoring, New York Times, October 7, 2007

Politics is the art of looking for trouble, finding it

everywhere,

diagnosing it incorrectly and applying the wrong

remedies.

Grouch Marx

Politician’s Emotional Statement and Some Facts: Dialogue Dispute vs Dishonest Discourse -A Case Study

Politician’s emotional statement: I am alive because I am free to choose my doctor (free enterprise), where as in other countries (socialized medicine) I cannot.

He claims these facts support his position: USA prostrate cancer survival rate is 82% and UK prostate cancer survival rate is 44%. But the facts involved are: The 44% figure is bogus, called “crude’ by the politician’s own consultant and disavowed by the Commonwealth Fund, the original source.

Giuliani’s Prostate Cancer Figure Is Disputed, New York Times, October 31, 2007

“No, no, you're not thinking;

you're just being logical.”

Niels Bohr

Cancer: A First and Last Word

“Because no cancer cell exists, the respiration of which is intact, it cannot be disputed that cancer could be prevented if the respiration of the body cells would be kept intact.”

“For cancer formation there is necessary not only an irreversible damaging of the respiration but also an increase in the fermentation.” (Fermentation is a way that cells with impaired respiration try to survive by converting body sugars [glucose] into a weak form of ATP energy.)

“The most important fact in this field is that there is no physical or chemical agent with which the fermentation of cells in the body can be increased directly: for increasing fermentation, a long time and many cell divisions are always necessary.”

“The mysterious latency period of the production of cancer is, therefore, nothing more than the time in which the fermentation increases after a damaging of the respiration.”

“There would be no cancers if there were no fermentation of normal body cells.”“Carcinogenesis by x-rays is obviously nothing else than destruction of

respiration by elimination of the respiring grana.” You kill cancer cells with radiation but you weaken healthier cells at the same time, so “…the descendents of the surviving normal cells may in the course of the latent period compensate the respiration decrease by the fermentation increase and thence become cancer cells.”

The Prime Cause and Prevention of Cancer, Revised Lindau Lecture, 1966, Otto Warburg, M.D., PhD (Chemistry), Noble Laureate, 1931, 1944; Director, Max Planck Institute for Cell Physiology, Berlin-Dahlem, Germany

• Solutions-change the thinking• Solutions-eliminate profit and advertising• Solutions-establish independent body-a public trust that

approves only what can be platinum standard validated• Solutions-convert everything that starts with or contains

the word medical into wellness and then make its parts comport to that goal

• Compensate based on results to prevent first and treat later

• Criminalize all activity that benefits an individual, institution or entity that is or appears as a conflict

• Make them wash their hands• Create a National Wellness Service