Sally Fallon and Mary G. Enig, PhD
printed at Weston
Honolulu Hearth Program (2001)
This report, part of an ongoing study, looked at cholesterol lowering
in the elderly. Researchers compared changes in cholesterol concentrations
over 20 years with all-cause mortality.34 To quote:
"Our data accords with previous findings of increased mortality
in elderly people with low serum cholesterol, and show that long-term
persistence of low cholesterol concentration actually increases
risk of death. Thus, the earlier that patients start to have lower
cholesterol concentrations, the greater the risk of death ...
The most striking findings were related to changes in cholesterol
between examination three (1971-74) and examination four (1991-93).
There are few studies that have cholesterol concentrations from
the same patients at both middle age and old age. Although our
results lend support to previous findings that low serum cholesterol
imparts a poor outlook when compared with higher concentrations
of cholesterol in elderly people, our data also suggest that those
individuals with a low serum cholesterol maintained over a 20-year
period will have the worst outlook for all-cause mortality [emphasis
The MIRACL study looked at the effects of a high dose of Lipitor
on 3,086 patients in the hospital after angina or nonfatal MI and
followed them for 16 weeks.35 According to the abstract: "For
patients with acute coronary syndrome, lipid-lowering therapy with
atorvastatin, 80 mg/day, reduced recurrent ischemic events in the
first 16 weeks, mostly recurrent symptomatic ischemia requiring
rehospitalization." What the abstract did not mention was that
there was no change in death rate compared to controls and no significant
change in re-infarction rate or need for resuscitation from cardiac
arrest. The only change was a significant drop in chest pain requiring
ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent
Heart Attack Trial), the largest North American cholesterol-lowering
trial ever and the largest trial in the world using Lipitor, showed
mortality of the treatment group and controls after three or six
years was identical.36
Researchers used data from more than 10,000 participants and followed
them over a period of four years, comparing the use of a statin
drug to "usual care," namely maintaining proper body weight,
no smoking, regular exercise, etc., in treating subjects with moderately
high levels of LDL cholesterol. Of the 5170 subjects in the group
that received statin drugs, 28 percent lowered their LDL cholesterol
significantly. And of the 5,185 usual-care subjects, about 11 percent
had a similar drop in LDL. But both groups showed the same rates
of death, heart attack and heart disease.
Heart Protection Study (2002)
Carried out at Oxford University,37 this study received widespread
press coverage; researchers claimed "massive benefits"
from cholesterol-lowering,38 leading one commentator to predict
that statin drugs were "the new aspirin."39 But as Dr.
Ravnskov points out,40 the benefits were far from massive. Those
who took simvastatin had an 87.1 percent survival rate after five
years compared to an 85.4 percent survival rate for the controls
and these results were independent of the amount of cholesterol
lowering. The authors of the Heart Protection Study never published
cumulative mortality data, even though they received many requests
to do so and even though they received funding and carried out a
study to look at cumulative data.
According to the authors, providing year-by-year mortality data
would be an "inappropriate" way of publishing their study
PROSPER (Prospective Study of Pravastatin in the Elderly at Risk)
studied the effect of pravastatin compared to placebo in two older
populations of patients of which 56 percent were primary prevention
cases (no past or symptomatic cardiovascular disease) and 44 percent
were secondary prevention cases (past or symptomatic cardiovascular
Pravastatin did not reduce total myocardial infarction or total
stroke in the primary prevention population but did so in the secondary.
However, measures of overall health impact in the combined populations,
total mortality and total serious adverse events were unchanged
by pravastatin as compared to the placebo and those in the treatment
group had increased cancer. In other words: not one life saved.
Japanese Lipid Intervention Trial was a six-year study of 47,294
patients treated with the same dose of simvastatin.43 Patients were
grouped by the amount of cholesterol lowering. Some patient had
no reduction in LDL levels, some had a moderate fall in LDL and
some had very large LDL reductions. The results: no correlation
between the amount of LDL lowering and death rate at five years.
Those with LDL cholesterol lower than 80 had a death rate of just
over 3.5 at five years; those whose LDL was over 200 had a death
rate of just over 3.5 at five years.
In a meta-analysis of 44 trials involving almost 10,000 patients,
the death rate was identical at 1 percent of patients in each of
the three groups--those taking atorvastatin (Lipitor), those taking
other statins and those taking nothing.44 Furthermore, 65 percent
of those on treatment versus 45 percent of the controls experienced
an adverse event. Researchers claimed that the incidence of adverse
effects was the same in all three groups, but 3 percent of the atorvastatin-treated
patients and 4 percent of those receiving other statins withdrew
due to treatment-associated adverse events, compared with 1 percent
of patients on the placebo.
Statins and Plaque (2003)
A study published in the American Journal of Cardiology casts serious
doubts on the commonly held belief that lowering your LDL-cholesterol,
the so-called bad cholesterol, is the most effective way to reduced
arterial plaque.45 Researchers at Beth Israel Medical Center in
New York City examined the coronary plaque buildup in 182 subjects
who took statin drugs to lower cholesterol levels. One group of
subjects used the drug aggressively (more than 80 mg per day) while
the balance of the subjects took less than 80 mg per day.
Using electron beam tomography, the researchers measured plaque
in all of the subjects before and after a study period of more than
one year. The subjects were generally successful in lowering their
cholesterol, but in the end there was no statistical difference
in the two groups in the progression of arterial calcified plaque.
On average, subjects in both groups showed a 9.2 percent increase
in plaque buildup.
Statins and Women (2003)
No study has shown a significant reduction in mortality in women
treated with statins. The University of British Columbia Therapeutics
Initiative came to the same conclusion, with the finding that statins
offer no benefit to women for prevention of heart disease.46 Yet
in February 2004, Circulation published an article in which more
than 20 organizations endorsed cardiovascular disease prevention
guidelines for women with several mentions of "preferably a
ASCOT-LLA (Anglo-Scandinavian Cardiac Outcomes Trial -- Lipid Lowering
Arm) was designed to assess the benefits of atorvastatin (Lipitor)
versus a placebo in patients who had high blood pressure with average
or lower-than-average cholesterol concentrations and at least three
other cardiovascular risk factors.48 The trial was originally planned
for five years but was stopped after a median follow-up of 3.3 years
because of a significant reduction in cardiac events. Lipitor did
reduce total myocardial infarction and total stroke; however, total
mortality was not significantly reduced. In fact, women were worse
off with treatment. The trial report stated that total serious adverse
events "did not differ between patients assigned atorvastatin
or placebo," but did not supply the actual numbers of serious
Cholesterol Levels in Dialysis Patients
In a study of dialysis patients, those with higher cholesterol
levels had lower mortality than those with low cholesterol.49 Yet
the authors claimed that the "inverse association of total
cholesterol level with mortality in dialysis patients is likely
due to the cholesterol-lowering effect of systemic inflammation
and malnutrition, not to a protective effect of high cholesterol
concentrations." Keeping an eye on further funding opportunities,
the authors concluded: "These findings support treatment of
hypercholesterolemia in this population."
Stay tuned for Part IV in the next issue of the newsletter.
Safety Concerns Surround
the Latest Statin, Crestor
Statin Drugs Are Now
Available Over the Counter
The Truth About Crestor: Is
Crestor Dangerous And, if so, Why?
The Truth About Cholesterol-Lowering
Drugs (Statins), Cholesterol, and Health
Crestor and Other Statins:
Are They Really Worth the Risk?
Half of Population Will be
Statins - Is the Danger is