Why treat nutritional deficiency with drugs?

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Orthomolecular Medicine News Service, November 13, 2008

Why treat nutritional deficiency with drugs?

(OMNS, November 13, 2008) A recent study suggested that statins might be used to
avoid the effects of nutritional deficiency. Writing in the New England Journal of
Medicine, the Jupiter group described a study of statin drugs in people with high
C-reactive protein and low cholesterol. (1) High C-reactive protein levels are
associated with inflammation and heart disease/stroke. The authors concluded that,
in apparently healthy persons with elevated C-reactive protein levels, rosuvastatin
(Crestor) significantly reduced the incidence of major cardiovascular events.

Their much-publicized claim, that this statin lowers the risk of heart attack by
approximately one half, is technically correct though highly misleading. The
reported annual incidence of coronary events was 37 people in 10,000 (controls) and
17 people in 10,000 (treated). Similar results were reported for risk of stroke.
When expressed as a proportion, a 46% improvement (17/37) sounds large. However, an
improvement of 20 events (37-17) in 10,000 people known to be at risk is less
impressive. Such an improvement means that 500 people (10,000/20) with this
increased risk would need to take the tablet daily for a year, to prevent one person
suffering an event.

The paper does not explicitly report deaths. One reason for this may be that if a
person on statins suffered a heart attack, that person was about three times more
likely to die than a control who was not on statins.

The cost of rosuvastatin per person is approximately $1000 per year. So, treating
enough people to prevent one heart attack costs $500,000 per year. Since about 70%
of the heart attacks were not fatal, prevention of a single death from heart attack
would cost even more, approximately $1,700,000. Giving the benefit of the doubt, we
may allow for a similar reduction in stroke and say that "only" $250,000 is needed
to protect one person from a stroke or heart attack. It is hardly surprising that
Astra Zeneca's share price increased by $1.3 billion dollars on release of this
paper and the corresponding media hype. (2)

The media suggested millions of healthy people could cut their risk of heart disease
by taking statins. (3) They also claimed that statins could cut the risk of heart
attack for "everyone". (4) This is inaccurate and incorrect. The study did not
include normal healthy people, only a sample of a relatively small number of people,
suffering from inflammation (increased C-reactive protein) - a known cause of heart
disease and stroke. Out of 89,890 people considered for inclusion, 17,802 people
(19.8%) met the specific criteria of poor health for the study. Widespread
prescription of statins to healthy people is not supported by these findings.

The fact that statins produce a modest improvement is unsurprising, since they are
known to lower inflammation, as do many nutritional supplements. As Bill Sardi has
pointed out, Crestor lowered C-reactive protein by 37%, but vitamin E lowers it by
32%, (5) and vitamin C by 25.3%. (6,7) These effects are similar to those of statins
and would be expected to provide comparable benefits, without side effects and at a
lower cost.

Crestor and other statin drugs have serious side effects. The incidence of
established side-effects, such as rhabdomyolysis (0.3 per 10,000 per year), myopathy
(1.1 per 10,000) and peripheral neuropathy (1.2 per 10,000 per year) seems low, (8)
but may be underestimated as it takes time to establish long-term side-effects. (The
depletion of coenzyme Q10 by statins is a particular concern.) The figures imply
that for every ten people who avoid a cardiovascular event, at least one previously
healthy person will suffer a non-trivial side effect of the statin drug.

The doctors reported a statistically significant increase (270) in diabetes in the
statin group compared to the placebo group (216). Over the course of the study, this
corresponds to an increased risk of approximately 61 in 10,000 people. So, the
number of people on statins reported to become diabetic was greater than the number
that avoided a heart attack! These people might have shorter lives and be at greater
risk of heart disease in the long term.

Notably, the Jupiter study was stopped early, which the authors admit prevents
assessment of how side-effects might outweigh reported benefits in the longer term.
The study was to last 3-5 years and the criteria for stopping were not included in
the original published design. (9) The paper claims that when the study was stopped
"these [diabetic] events were not adjudicated by the end-point committee". The
committee either knew about the diabetes in which case it was considered, or it did
not and the committee was not doing its job properly.

The Jupiter name stands for Justification for the Use of statins in Prevention: an
Intervention Trial Evaluating Rosuvastatin; the reader might think this
"justification" sounds more like a marketing plan than a scientific endeavor. The
researchers did not address the underlying cause of the inflammation and increased
C-reactive protein: they simply treated the condition with drugs. In many cases,
raised C-reactive protein is a result of nutritional deficiency. (10)

It is worth mentioning that several nutritional supplements inhibit inflammation and
lower C-reactive protein, without causing known side effects. Deficiency in vitamins
A, (11) B6, C, E, A, folate, carotenoids and lycopene, (12) and selenium (for
example) is associated with raised C-reactive protein. (13,14,15) We suggest that
the $250,000 cost of preventing a single cardiovascular event with rosuvastatin
might be better spent funding a study of such inexpensive alternatives the
deficiency of which may be the cause of the problem.

The people at risk could be encouraged to supplement their diet and restore their
health without using these expensive drugs to conceal their underlying sickness.

Stick with the supplements!

References:

(1) Ridker P.M. Danielson E. Fonseca F.A.H. Genest J. Gotto A.M. Kastelein J.J.P.
Koenig W. Libby P. Lorenzatti A.J. MacFadyen J.G. Nordestgaard B.G. Shepherd J.
Willerson J.T. Glynn R.J. for the JUPITER Study Group (2008) Rosuvastatin to Prevent
Vascular Events in Men and Women with Elevated C-Reactive Protein, NEJM, 359(21),
2195-2207.

(2) Mail Online (2008) Crestor news helps AstraZeneca market value leap by more than
£1.3bn, 9:25 PM, 10th Nov.

(3) Smith R. (2008) Millions could cut heart attack risk by taking statins, study
finds, telegraph.co.uk, 7:55AM GMT, 10 Nov.

(4) Hope J. (2008) The new statin drug that cuts the risk of heart attacks and
strokes for EVERYONE, Daily Mail, 11th Nov.

(5) Devaraj S. Tang R. Adams-Huet B. Harris A. Seenivasan T. de Lemos J.A. Jialal I.
(2007) Effect of high-dose alpha-tocopherol supplementation on biomarkers of
oxidative stress and inflammation and carotid atherosclerosis in patients with
coronary artery disease, Am J Clin Nutr, 86(5), 1392-1398.

(6) Block G. Jensen C.D. Dalvi T.B. Norkus E.P. Hudes M. Crawford P.B. Holland N.
Fung E.B. Schumacher L. Harmatz P. (2008) Vitamin C treatment reduces elevated
C-reactive protein, Free Radic Biol Med, Oct 10. [Epub]

(7) Sardi B. (2008) The Headline You Should Be Reading: Statin Drugs Don't Save
Lives And May Increase Your Risk For Diabetes, Knowledge of Health Report, Nov 11.

(8) Law M. Rudnicka A.R. Statin Safety: A Systematic Review, The American Journal of
Cardiology, 97(8), Suppl 1, S52-S60.

(9) Ridker P.M. JUPITER Study Group (2003) Rosuvastatin in the primary prevention of
cardiovascular disease among patients with low levels of low-density lipoprotein
cholesterol and elevated high-sensitivity C-reactive protein: rationale and design
of the JUPITER trial, Circulation, 108(19), 2292-2297.

(10) Ford E.S. Liu S. Mannino D.M. Giles W.H. Smith S.J. (2003) C-reactive protein
concentration and concentrations of blood vitamins, carotenoids, and selenium among
United States adults, European Journal of Clinical Nutrition, 57, 1157-1163.

(11) Root M.M. Hu J. Stephenson L.S. Parker R.S. Campbell T.C. (1999) Determinants
of plasma retinol concentrations of middle-aged women in rural China. Nutrition 15,
101-107.

(12) Boosalis M.G. Snowdon D.A. Tully C.L. Gross M.D. (1996): Acute phase response
and plasma carotenoid concentrations in older women: findings from the nun study,
Nutrition, 12, 475-478.

(13) Friso S. Jacques P.F. Wilson P.W. Rosenberg I.H. Selhub J.(2001) Low
circulating vitamin B(6) is associated with elevation of the inflammation marker
C-reactive protein independently of plasma homocysteine levels, Circulation,
103(23), 2788-2791.

(14) Devaraja S. Jialal I. (2000) Alpha tocopherol supplementation decreases serum
C-reactive protein and monocyte interleukin-6 levels in normal volunteers and type 2
diabetic patients, Free Radical Biology and Medicine, 29(8), 790-792.

(15) Upritchard J.E. Sutherland W.H. Mann J.I. (2000): Effect of supplementation
with tomato juice, vitamin E, and vitamin C on LDL oxidation and products of
inflammatory activity in type 2 diabetes, Diabetes Care, 23, 733-738.

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Editorial Review Board:

Damien Downing, M.D.
Harold D. Foster, Ph.D.
Steve Hickey, Ph.D.
Abram Hoffer, M.D., Ph.D.
James A. Jackson, PhD
Bo H. Jonsson, MD, Ph.D
Thomas Levy, M.D., J.D.
Erik Paterson, M.D.
Gert E. Shuitemaker, Ph.D.

Andrew W. Saul, Ph.D., Editor and contact person. Email: omns@orthomolecular.org

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