The Vitamin D Newsletter
March 1, 2006
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periodic publication of the Vitamin D Council. If you don't want
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Newsletter Page.
Dr. Jean
Wactawski-Wende, the New England
Journal of Medicine, and Ethics.
Good research is good for medicine. The only thing more
important than good research is ethical research. The February 16, 2006, issue
of the New England Journal of Medicine (NEJM) had a research paper on vitamin
D and colon cancer. Was it good research?
Was it ethical research? At stake are the lives of 36,000 older American women
who agreed to participate in the Women's Health
Initiative.
Dr. Wactawski-Wende confirmed what we already knew: 400 units
of vitamin D per day do not protect anyone from colon cancer. No news there.
Such a small dose is unlikely to protect anyone from any cancer; although a
recent meta-analysis concluded 1,000 units a day may prevent one-half of all
human cancers. Adequate doses (2,000 units per day) may prevent even more
cancers.
We have known for ten years that 400 units of vitamin D will
do little except maintain blood calcium. Think of vitamin D requirements as
a series of pools along a mountain stream. The top pool is the endocrine
function of vitamin D. Below are numerous autocrine pools having to do with preventing
cancer, heart disease, autoimmune disease, depression, gum disease, stroke,
dementia, etc.
Vitamin D in the top pool has only one function: prevent your
blood calcium from falling too low. When the top pool gets too low, you die
from low blood calcium, so the body maintains the top pool at all costs and
at the expense of all the pools beneath it. Only when the top pool is full,
does any vitamin D flow down to the pools below, into all the other pools
associated with preventing a wide variety of disease. Four hundred units a
day barely fills the top pool, leaving none for the pools below.
Increasingly, and beginning in 1985, it looked as if one of
the downstream pools was the prevention of colon cancer. There are other
pools, but the colon cancer pool is pretty clear. The point is 400 units a
day can't help prevent colon cancer because it's barely enough to maintain blood
calcium; it never gets out of the top pool. ; I won't list all the
evidence that vitamin D helps prevent colon cancer but the last three papers are
recent reviews.
Dr. Wactawski-Wende selected 18,000 older women and only gave
them enough vitamin D to maintain their top pool, explicitly instructing the
patients not to take additional vitamin D! She wanted to see how many women
developed colon cancer and how many died from all causes. Even when the study
began (1998) such a small dose of vitamin D was unethical to give many older
women.
Beginning in 1997, the Institute of Medicine recommended
600 units a day, not 400, for everyone over the age of seventy, and
a number of Wactawski-Wende's subjects were older than 70. As the years
passed, hundreds of studies indicated 400 units does nothing but prevent low
blood calcium and perhaps retard bone disease. No one who has followed the
literature thinks 400 units a day will do anything more. In spite of this, she
continued giving older women only 400 units a day right up to 2005 - including the women over
70 - and she did so in the name of science. Shame.
The ethics get worse. She advised an additional 18,000
women to take a placebo that contained no
vitamin D, not even enough to prevent low blood calcium and osteomalacia!
Such recommendations fly in the face of every advisory board and expert panel in
the world. The Institute of Medicine's Food and Nutrition Board, the FDA, the
NIH, etc, all recommend women over the age of fifty ;take at least 400
units of vitamin D a day and women over 70 take 600 units a day. They
instituted those recommendations in 1997. In 1998, Dr. Wactawski-Wende told
18,000 older ;American women to take
no vitamin D at all, and she did so right up to 2005 - so she could experiment
on them. Shame.
Is there ;evidence Dr. Wactawski-Wende knew her actions
were unethical? Any evidence the editors of the NEJM helped cover it up? Yes,
buried in the article was the study's principal finding. Women with the
lowest initial vitamin D levels were 2.5 times more likely to develop colon
cancer! More than 300 of the women developed colon cancer during the study
and some died. Women with the highest blood levels, levels not obtainable with
400 units a day, levels that had to be obtained by sun exposure, were much less
likely to get colon cancer. Shame.
Furthermore, the authors found 63 more deaths in the placebo
group, a finding that only had a 7% likelihood of being by chance alone. That is
there was a clear trend (0.07) towards significance in all-cause mortality; even
by taking only 400 units a day, the vitamin D group lived longer. Was
either of these life-saving pieces of information in the abstract? No. Dr.
Wactawski-Wende buried them deep in the paper. She devoted two
sentences to the protective effects of high vitamin D levels and nothing at
all to the trend in all-cause mortality - as if she didn't want us to know.
Shame.
But the ethics get even worse. Physicians are ethically
obligated to treat conditions they diagnose. The 36,000 women in the study had
blood drawn at the beginning of the study. How many of those women were vitamin
D deficient? Most of them. The average vitamin D level was only 16.8 ng/ml,
clearly deficient. Twenty-five percent of the women had levels below 12.4 ng/ml,
close to the osteomalacic range. The 25(OH)D levels were assayed by
Professor Bruce Hollis, using the gold standard for such assays. Were these
women told they were vitamin D deficient? Did Dr. Wactawski-Wende obtain
informed consent to experiment on vitamin D deficient women by telling them
their deficiency would not be treated? No. Shame.
Furthermore, some of the women were African American. We
know many of the women with the lowest levels were African American because
every study of 25(OH)D levels shows African Americans have much lower levels
than whites. What did Dr. Wactawski-Wende
do to address this racial inequity? What did she do to help the African American
women with vitamin D deficiency? Nothing, she was too busy experimenting on
them. Shame, shame, shame.
And what plans does she have for these women? Continued
experimentation. Eighteen thousand women will continue getting an inadequate
dose of vitamin D and 18,000 women will get none. All in the name of science.
Shame. Shame on Dr. Wactawski-Wende and shame on the editors of the New England
Journal of Medicine.
What can you do? Ask around; find some of the 36,000 women in
the Women's Health Initiative. Tell them the truth, show them the science, and
get them on adequate doses of vitamin D. If you find any of the women who
developed colon cancer or who died, refer
them or their families to me and I'll find them a good plaintiff's
attorney.
John Cannell, MD
The Vitamin D Council
9100 San Gregorio Road
Atascadero, CA 93422
Remember, we are a tax-exempt non-profit working to end the
epidemic of vitamin D deficiency. We rely on contributions to maintain our
website and distribute our newsletter. Make tax-deductible checks out to the
Vitamin D Council and send them to:
The Vitamin D Council
9100 San Gregorio Road
Atascadero, CA 93422
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