Healthy Skepticism Library item: 49

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Publication type: news

Rabin R.
Pill study was wrong: Report touting health benefits from drug's use was flawed, didn't get OK from Women's Health Initiative
Newsday 2004 Dec 10

Full text:

Top Women’s Health Initiative scientists yesterday repudiated a widely publicized recent study about the birth control pill, saying the report that had been touted as a product of the initiative was unauthorized, seriously flawed and simply wrong.

The rogue study concluded birth control pills protect women from heart disease and cancer later in life. But when WHI scientists did their own analysis, they found the health disparities were primarily a result of age
differences: the older the women were, the less likely they were to have ever used the pill and the more likely they were to have heart disease or cancer, diseases associated with aging.

The nearly 162,000 women enrolled in the initiative were 50 to 79 years old when the trials started.

“WHI has reviewed this study from Wayne State University and found that it is flawed,” said Dr. Jacques Rossouw, project officer of the Women’s Health Initiative. “It’s not a WHI study, and the presentation was not made on behalf of the WHI. The findings are not credible. … We really need to set the record straight.

“I don’t even understand why they did this analysis. … It doesn’t make sense. Why would oral contraceptive use many decades previously have an effect on current health?”

He said age was just one of the biases that marred the oral contraceptive report, noting another flaw, called survivor bias. The Women’s Health Initiative enrolled generally healthy women, and there was no way to account for the missing women who might have been casualties of the pill’s serious adverse effects. “Anyone who used oral contraceptives in the past and died as a complication of oral contraceptives, like stroke or cancer, would not be enrolled,” Rossouw said.

The study was presented publicly as being derived from the WHI database, which “gave it a false credibility,” he noted.

The confusing findings could have serious health implications, Rossouw said.
About 10 million American women use the birth control pill, which is known to increase the risks of heart attack, stroke and potentially fatal blood clots, cervical cancer, liver cancer and, in some women, breast cancer.
Birth control pill use may reduce the risk of ovarian cancer.

The university study implied women could disregard health risk warnings, and even suggested the pill should be taken as a protective measure to reduce the the risk of cancer.

The Wayne State University researchers, including Drs. Rahi Victory, Michael Diamond and Susan Hendrix, have not returned calls for comment.

WHI officials said they used the WHI data without proper authorization, never sought approval from the WHI for their analysis and never subjected their work to the initiative’s rigorous scientific review process.

An internal WHI memo obtained by Newsday offers investigators and staff a dozen detailed “talking points” that undermine the design and credibility of the study.

WHI officials have handled the affair gingerly since Wayne State researchers presented it at a medical meeting in October. The university’s obstetric and gynecology department received more than $16 million in grants from the National Institutes of Health this year, making it the top recipient of NIH grants in the country, according to the university’s Web site.