2004N-0242 - INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS
FDA Comment Number : EC2
Submitter : Mr. Br Daniel Izzo Date & Time: 07/21/2004 11:07:20
Organization : Cryonic Life Insurance Company
Private Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
Dear FDA:

250,000 deaths in the US every year are Doctor Errors

Internet report for 7/30/200 JAMA report from Dr Joseph Mercola referenced site below:

Doctors Are The Third Leading Cause of Death in the US, Causing 250,000 Deaths Every Year

This article in the Journal of the American Medical Association (JAMA) is the best article I have ever seen written in the published literature documenting the tragedy of the traditional medical paradigm.

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This information is a followup of the Institute of Medicine report which hit the papers in December of last year, but the data was hard to reference as it was not in peer-reviewed journal. Now it is published in JAMA which is the most widely circulated medical periodical in the world.

The author is Dr. Barbara Starfield of the Johns Hopkins School of Hygiene and Public Health and she desribes how the US health care system may contribute to poor health.

ALL THESE ARE DEATHS PER YEAR:

12,000 -- unnecessary surgery 8
7,000 -- medication errors in hospitals 9
20,000 -- other errors in hospitals 10
80,000 -- infections in hospitals 10
106,000 -- non-error, negative effects of drugs 2
These total to 250,000 deaths per year from iatrogenic causes!!
What does the word iatrogenic mean? This term is defined as induced in a patient by a physician's activity, manner, or therapy. Used especially of a complication of treatment.

Dr. Starfield offers several warnings in interpreting these numbers:

First, most of the data are derived from studies in hospitalized patients.
Second, these estimates are for deaths only and do not include negative effects that are associated with disability or discomfort.
Third, the estimates of death due to error are lower than those in the IOM report.1
If the higher estimates are used, the deaths due to iatrogenic causes would range from 230,000 to 284,000. In any case, 225,000 deaths per year constitutes the third leading cause of death in the United States, after deaths from heart disease and cancer. Even if these figures are overestimated, there is a wide margin between these numbers of deaths and the next leading cause of death (cerebrovascular disease).

Another analysis concluded that between 4% and 18% of consecutive patients experience negative effects in outpatient settings,with:

116 million extra physician visits
77 million extra prescriptions
17 million emergency department visits
8 million hospitalizations
3 million long-term admissions
199,000 additional deaths
$77 billion in extra costs
The high cost of the health care system is considered to be a deficit, but seems to be tolerated under the assumption that better health results from more expensive care.

However, evidence from a few studies indicates that as many as 20% to 30% of patients receive inappropriate care.

An estimated 44,000 to 98,000 among them die each year as a result of medical errors.2

This might be tolerated if it resulted in better health, but does it? Of 13 countries in a recent comparison,3,4 the United States ranks an average of 12th (second from the bottom) for 16 available health indicators. More specifically, the ranking of the US on several indicators was:

13th (last) for low-birth-weight percentages
13th for neonatal mortality and infant mortality overall 14
11th for postneonatal mortality
13th for years of potential life lost (excluding external causes)
11th for life expectancy at 1 year for females, 12th for males
10th for life expectancy at 15 years for females, 12th for males
10th for life expectancy at 40 years for females, 9th for males
7th for life expectancy at 65 years for females, 7th for males
3rd for life expectancy at 80 years for females, 3rd for males
10th for age-adjusted mortality
The poor performance of the US was recently confirmed