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To: Stephen O who wrote (310)9/17/2003 7:41:39 PM
From: RealMuLan  Read Replies (1) | Respond to of 108726
 
will most of US doctors "buy" the research? Because few patients would ever pay attention to research. And what if most of doctors won't budge, and continue to prescribe the drug?



To: Stephen O who wrote (310)9/17/2003 8:26:43 PM
From: BubbaFred  Respond to of 108726
 
Analysis of serious adverse events

Lipid-lowering therapy revisited

Jim M. Wright, MD, PHD, FRCPC Lorri Puil, MD, PHD Carol Lee Ken Bassett, MD, PHD

A recent paper documented underreporting of safety data in published randomized controlled trials (RCTs).1 Serious adverse events (SAEs) are one component of safety and are potentially the most important outcome measure in RCTs. Regulatory bodies require data on SAEs to be collected in all clinical trials.

Serious adverse events include any untoward medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, or result in persistent or severe disability.2 Because total SAEs include benefit and harm, the total percentage of SAEs provides a useful single measure of the overall health effects of a particular intervention.

Combined outcomes in SAE analysis

Serious adverse event analysis is particularly relevant for RCTs in which the goal of therapy is to reduce death and life-threatening events (eg, lipid-lowering therapy trials). Therapeutics Letters no. 243 and no. 274 presented the benefit of lipid-lowering therapy in terms of a common outcome: incidence of total myocardial infarction (MI) or cardiovascular (CV) death.

This combined outcome is also included in total percentage of SAEs. If, for example, a statin decreases total MIs or CV deaths and has no serious adverse consequences, the health benefit will be seen as a decrease in both the defined outcome and in percentage of SAEs compared with placebo. If, however, the statin increases other SAEs, in addition to reducing the defined outcome, then the total percentage of SAEs might be unchanged or even increased as compared with placebo.

Are SAEs reported in major lipid-lowering trials?

We looked for SAE data in the major placebo-controlled trials published up to September 2001 using statins (five trials)5-9 or fibrates (five trials).10-14 Remarkably, only one study, the Air Force Coronary Atherosclerosis Prevention Study (AFCAPS) trial,5 reported total percentage of SAEs in treatment and placebo groups. The AFCAPS trial compared lovastatin with placebo in patients without CV disease (primary prevention). Similar total percentage of SAEs was reported for lovastatin (34.2%) and placebo groups (34.1%) (relative risk [RR] 1.0; 95% confidence interval [CI] 0.94 to 1.07).

What this indicates is that the 1.4% absolute risk reduction for total MI or CV death (see the table in Therapeutics Letter no. 274) has been negated by an absolute risk increase in other SAEs. No information is provided as to what these other SAEs are. The only other trial that reported anything approximating SAEs was the Coronary Drug Project, a secondary prevention trial. This trial reported the percentage of patients ever hospitalized by 5 years after the trial: 55.1% in the clofibrate treatment arm; 52.4% in the placebo group (RR 1.05; 95% CI 0.99 to 1.12).10

What can be learned from all-cause mortality?

Total percentage of SAEs can be divided into all-cause mortality and life-threatening events. All-cause mortality was reported in all trials. Analysis of this outcome is summarized in Table 1.5-14

These data demonstrate a substantial benefit in regard to mortality for statins in secondary prevention (RR < 1; 95% CI not including 1), but not for any other clinical settings. A constant percentage of life-threatening events is predictably fatal in any particular RCT. Thus the RR for total mortality should reflect the RR for total SAEs. That is the case for the two instances here; the AFCAPS’ RR for SAEs was 1.00, and the Coronary Drug Project’s RR for hospitalizations was 1.05; both are similar to respective mortality RRs in Table 1.5-14

Conclusion

Total percentage of SAEs is an important measure of the health effect of a drug.• Total percentage of SAEs is often not reported in published RCTs, including lipid-lowering trials.
Mortality analysis supports use of statins for secondary prevention.
Analysis of SAEs and mortality does not support use of statins for primary prevention or use of fibrates for primary or secondary prevention.
Acknowledgment

cfpc.ca

I use Google's "I'm feeling lucky" search with key words "Jim Wright ubc cholesterol"



To: Stephen O who wrote (310)9/20/2003 3:34:33 PM
From: Yogizuna  Respond to of 108726
 
I found this extremely interesting.

XTEND-YOUR-LIFE Newsletter
Issue - 17th September 2003
By Warren Matthews
------------------------------------------------------------
THE 3RD BIGGEST CAUSE OF DEATH
------------------------------------------------------------************************************************************Note: Warren is literally marooned on a remote island 100 miles south of Fiji. Their phone systems have broken down so he can't transmit the newsletter. The adjoining village's phone is also broken. He got a message to me by relaying messages though several villages via radio telephone until he found one that had a phone that worked and could call us in New Zealand. Warren asked me for this week to republish an article that he wrote back in 6th February 2002 last year. Here it is... hope you enjoy it.
------------------------------------------------------------Read this issue online:
wz.xtend-life.com

AOL Users:
<a href="http://wz.xtend-life.com/xyl_43">Click here</a>

It will surprise you!

Did you know that if you become ill and you put yourself in the hands of 'mainstream' medical care and need to be
admitted to hospital that the chances of you dying from
an unrelated problem are high?

In fact, in the USA, deaths from 'iatrogenic' cause rank # 3 after Heart Diseases and Cancer!

Let me explain what 'iatrogenic' means. This is a term used when a patient dies as a direct result of treatments by a physician, whether it is from misdiagnosis of the ailment or from adverse drug reactions used to treat the illness. (drug reactions are the most common cause).

Today's newsletter will provide you with some facts which you should be aware of. I am not presenting these facts in order to have a 'shot' at physicians or indeed for that matter, hospitals.
------------------------------------------------------------'HEALTH CARE SYSTEM' IS OUT OF CONTROL!
------------------------------------------------------------The facts you are about to read are purely symptoms of a system that is largely out of control. Out of control, thanks largely to the overbearing influence that the pharmaceutical industry has on mainstream medicine. Mainstream medicine has for some decades now placed more emphasis on medical intervention as opposed to primary care, prevention, and helping the body heal itself by natural methods.
The negative results of these policies which can never work are becoming more apparent each year. To determine how serious the problem is you need to consider some statistics.
Ironically the most reliable statistics have been published in none other that the JOURNAL of the AMERICAN MEDICAL ASSOCIATION (JAMA) Vol 284, No 4, July 26th 2000.

The researcher who wrote the article is Dr Barbara Starfield, MD, MPH, of the Johns Hopkins School of Hygiene and Public Health.

Now let's review what Dr Starfield has unearthed! -------------------------------------------------------------
'THE FACTS' There Are....

2,000 deaths/year from unnecessary surgery.

7000 deaths/year from medication errors in hospitals.

20,000 deaths/year from other errors in hospitals.

80,000 deaths/year from nosocomial infections in hospitals.

106,000 deaths/year from non-error, adverse effects of
medications.

These total up to 225,000 deaths per year in the US from
iatrogenic causes which ranks these deaths as the # 3 killer.
Well above motor vehicle accidents and violent crime.

One of the most sobering components of these statistics,
although I don't find it surprising is that 106,000 of these deaths result from CORRECTLY prescribed medications. In other words the physicians were not to blame. They just administered the drugs as per the manufacturer's recommendations. --------------------------------------------------------------
'MORE DEATHS FROM LEGAL DRUGS THAN FROM ILLICIT ONES'
------------------------------------------------------------
Fascinating isn't it... when you consider that deaths from legal drugs far exceed deaths from illicit drugs and yet these deaths go virtually unnoticed and nobody makes a fuss!
Dr Starfield also warns that these figures only tell one part of the overall story.

1. They only relate to DEATHS from HOSPITALIZED patients.

2. They do NOT include non fatal adverse effects such as
disability or discomfort.

Even if you make it through the hospitalization process you are not 'out of the woods'. Consider these further facts.
4% - 18% of patients experience further negative effects in outpatient settings resulting in the following:

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.

------------------------------------------------------------'IS THIS JUST THE TIP OF THE ICEBERG?'
------------------------------------------------------------
With human nature being as it is you can rest assured that the above 'official' figures are just the 'tip of the iceberg'. I have no doubt that for each 'official' iatrogenic death that there are others which are recorded as 'legitimate' deaths.
As an example... when a patient dies of a heart attack in hospital whilst being treated for something else its easy enough to dismiss it as 'bad luck' and write it off to the fact that the patient had a bad heart and that they just happened to be in hospital at the time when the heart attack occurred.
Is the hospital or physician going to tell the patient's family that perhaps some of the treatments the patient was having could have precipitated the heart 'event'? In these days of litigation I don't think so... if they can avoid it.
I have no doubt that hospitals are the equal of politicians when it comes to 'cover ups'.
OK, I've said my bit about this problem and I am sure that you have the message, so what's the point of knowing these sad facts?
Avoid falling into the hands of hospitals and the 'health'
system, because it can make you sick...OR EVEN KILL YOU! This means that you must be constantly aware of the health demands on your body such as the need to give it correct food, adequate exercise and rest, and of course adequate intakes of essential nutrients.
Liken it to your car... give it poor fuel and neglect the
maintenance and it will either run badly or stop altogether.
------------------------------------------------------------'IT'S NOT NATURAL TO BE ILL'
------------------------------------------------------------Illness is UNNATURAL and can generally be avoided. The cause of almost all illness is people doing unnatural things to their body, whether it is due to the environment they live in, the food and liquids that they ingest, or living the life of a 'couch potato'.
Each person controls their own health OR illness, not their physician or their 'Health Care' provider.
I am sure that you are aware that the average diet is very much lacking in essential nutrients due to the high level of food processing, exposure to toxins such as pesticides etc, etc.
The lack of these essential nutrients has been shown to
'trigger' off many ailments which can start a cascade effect and lead to serious problems in the future.
The lack of these nutrients can be largely overcome in most people by dietary supplementation. The problem is getting ALL the nutrients into your body in the correct proportion.

In the next issue of 'XTEND-YOUR-LIFE' I am going to bring you some more startling facts about the state of the 'Healthcare' system and why it is so crucial you avoid being caught up in it.

Until our next issue,

In good health,

Warren Matthews

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