The Vitamin D Council - Dr. Jean Wactawski-Wende

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" The Vitamin D Council " <jcannell

Dr. Jean Wactawski-Wende

Sun, 26 Feb 2006 17:04:04 -0800

 

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The Vitamin D Newsletter

March 1, 2006

 

 

This is a periodic publication of the Vitamin D Council. If you don't

want to get this newsletter, please, please, please, hit reply and let

me know. This newsletter is not copyrighted. Please reproduce it and

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D Council's 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.

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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The Vitamin D Council

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Atascadero, CA 93422

 

This is a periodic publication of the Vitamin D Council. If you don't

want to get this newsletter, please hit reply and let me know. This

newsletter is not copyrighted. Please reproduce it and post it on

internet sites. I will post this newsletter on the Vitamin D Council's

Newsletter Page.