Vitamin D Newsletter

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.
N Engl J Med. 2006 Feb 16;354(7):684-96.


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.
Am J Public Health. 2006 Feb;96(2):252-61. Epub 2005 Dec 27.


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.
Lancet. 1985 Feb 9;1(8424):307-9.
Nutr Cancer. 2004;48(2):115-23.
Int J Epidemiol. 2005 Nov 22; [Epub ahead of print]
Curr Opin Gastroenterol. 2006 Jan;22(1):24-9.


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.

Am J Clin Nutr. 2002 Jul;76(1):187-92.
Ethn Dis. 2005 Autumn;15(4 Suppl 5):S5-97-101.


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

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