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The Vitamin D Newsletter March 2006

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Dr. Wactawski-Wende, 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 16th 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. Wactawski-Wende J, et al. Calcium plus vitamin D supplementation and the risk of colorectal cancer. N Engl J Med. 2006 Feb 16;354(7):684–96.

400 Units Per Day Not Enough

Dr. Wactawski-Wende confirmed what was already known: 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. Garland CF, Garland FC, Gorham ED, Lipkin M, Newmark H, Mohr SB, Holick MF. The role of vitamin D in cancer prevention. Am J Public Health. 2006 Feb;96(2):252–61.

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. If the top pool's levels of vitamin D become insufficient, death from low blood calcium would result. Hence, the body will work to maintain the top pool at all costs—at the expense of all the other pools beneath it. Only when the top pool is full does any vitamin D flow downstream. Since 1985, there has been increasing evidence that one of those downstream pools is for the prevention of colon cancer. Well, 400 units a day is barely enough to fill the top pool (maintain normal blood calcium), leaving none for disease fighting in the pools below. Garland C, Shekelle RB, Barrett-Connor E, Criqui MH, Rossof AH, Paul O. Dietary vitamin D and calcium and risk of colorectal cancer: a 19-year prospective study in men. Lancet. 1985 Feb 9;1(8424):307–9. Grant WB, Garland CF. A critical review of studies on vitamin D in relation to colorectal cancer. Nutr Cancer. 2004;48(2):115–23. Giovannucci E. Commentary: vitamin D and colorectal cancer--twenty-five years later. Int J Epidemiol. 2006 Apr;35(2):222–4. Giovannucci E. The epidemiology of vitamin D and colorectal cancer: recent findings. 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 considered unethical to give many older women.

In the Name of Science

A year prior to this, in 1997, the Institute of Medicine set its recommendation at 600 units per day (not 400) for everyone over the age of seventy—which a number of Wactawski-Wende's subjects were. As she continued her study and the years passed, hundreds of other studies were published indicating that 400 units does nothing but prevent low blood calcium and perhaps retard bone disease (in fact, no one who has followed the literature thinks 400 units a day will do anything more). Yet, in spite of this, she continued to give the older women only 400 units a day, right up to 2005 (including those over 70), and did so in the name of science.

But wait, the lack of ethics gets even worse. She advised an additional 18,000 women to take a placebo that contained no vitamin D at all, 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 per day and those over seventy take 600 units—remember, they instituted those recommendations in 1997. Despite this, one year later Dr. Wactawski-Wende is instructing 18,000 older American women to take no vitamin D at all, having them do so until 2005—just so she could experiment on them, all in the name of science.

Results of Study Self-Incriminating

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.

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, yet nothing at all to the trend in all-cause mortality—as if she didn't want us to know.

Diagnosed Deficiency Left Untreated

Unfortunately, it still gets 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. 25% 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, she did not.

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 vitamin D 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. Giovannucci E. The epidemiology of vitamin D and colorectal cancer: recent findings. Am J Clin Nutr. 2002 Jul;76(1):187–92. Giovannucci E. The epidemiology of vitamin D and colorectal cancer: recent findings. Ethn Dis. 2005 Autumn;15(4 Suppl 5):S5-97–101.

And what plans does she have for these women? Continued experimentation, that's what. 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 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 the families of those who died, refer them to me and I'll help them find a good plaintiff's attorney.

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John Jacob Cannell MD Executive Director

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.