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Newsletter: New England journal of medicine and ethics

Posted on: March 1, 2006   by  John Cannell, MD


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.

Wactaeski-wende J, et al. Calcium plus vitamin D supplementation and the risk of colorectal cancer. N Engl J Med. 2006.

Dr. Wactawski-Wende confirmed what we already knew: 400 units of vitamin D per day does 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 day may prevent one-half of all human cancers. Adequate doses (2,000 units per day) may prevent even more cancers.

Garland CF, et al. The role of vitamin D in cancer prevention. Am J Public Health. 2006.

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.1, 2, 3, 4

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.5, 6

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.

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