The NIH issued a statement today stating that although the data are preliminary they appear to show, among other things, that, as compared to placebo, oral estrogen alone taken by women between 50 and 79, for up to seven years, caused no increased risk of breast cancer or heart disease. As in the previously published WHI study, a benefit in preventing hip fractures and an increased risk for stroke were identified in this older population. The NIH has determined that the results would not likely change if the estrogen trial continued to its planned completion in 2005. A full report of the results is expected in the next two months.Did you catch it? The critical health warning? Here's the un-spun version:
It is important to note that the study did not find an increase in the risk of breast cancer.
A large federal study of estrogen therapy in postmenopausal women has been stopped a year ahead of schedule because the hormone increased the risk of stroke and offered no protection against heart disease, the government announced yesterday.Notice how, in the drug company press release, NIH's decision to stop the study for safety reasons has been blanded down to "The NIH has determined that the results would not likely change if the estrogen trial continued." Yes indeed, and the particular result the NIH thought wouldn't change was that the study participants would continue to be at increased risk of stroke.
The study included only women taking estrogen alone, not those who take combined hormones. An earlier study, halted abruptly in 2002 after the researchers found an increased risk of breast cancer, involved only women taking the combined hormones estrogen and progestin.
The National Institutes of Health, which sponsored the estrogen study, part of the Women's Health Initiative, said it stopped the study because ``an increased risk of stroke is not acceptable in healthy women in a research study.''
I was particularly struck by this quote from the New York Times article:
Dr. James Simon, president of the North American Menopause Society, said, ``I think the findings for women are actually quite reassuring, namely that the major issue which women fear, breast cancer, was not increased on estrogen alone after approximately seven years.''What struck me as funny was that Dr. Simon said the study was good news with respect to "the major issue which women fear," and not, for example, "the major issue which endangers women's health." So I checked the National Vital Statistics Reports, and suddenly his wording made a lot more sense. In 2001, 100,361 American women died of cerebrovascular disease (strokes). According to the American Cancer Society, in the same year an estimated 40,200 women died of breast cancer. In other words, women are more than twice as likely to die from a stroke as they are to die from breast cancer.
So the estrogen study didn't show an increased risk for the feared result, just an increased risk for the more deadly result - and that's supposed to be good news for women? It seemed unlikely, so I checked Dr. Simon's quote again. And in fact, he doesn't say that the study is "good news" for women - he says it's "quite reassuring" for women. It calms their fears of getting breast cancer, and makes them feel safer about taking a drug that increases their risk of stroke. Aren't you reassured?
(I wouldn't be giving Dr. Simon such a hard time about his precise wording if it weren't for the fact that the confusion of "feeling safe" with "being safe" is so often a deliberate PR move. This guy is smart enough and well-educated enough to understand the relative risks involved. I don't think it's an accident that his comment echoes the drug company's own spin so precisely.)