Women's Group Expresses Concern about Misrepresentation of Pill Data, Questions Drug Company Influence over ResearchersMonday, July 26 2010
Women around the world have been misled about the benefits of the pill by a widely reported, but poor quality study. Information being presented at an NIH meeting later this week now makes clear that the October announcement of a report purporting to show the pills beneficial effect on cancer and heart disease was based on superficial data and an unscientific analysis.
Women need to know that the headlines claiming that birth control pills reduce the risk of heart disease, stroke and some cancers were wrong,says Cynthia Pearson, Executive Director of the National Womens Health Network. Those headlines were based on a preliminary report which has now been discredited
The report now under dispute was originally presented at a meeting of the American Society of Reproductive Medicine in Philadelphia on October 20th. Dr. Rahi Victory and a group from Wayne State University Medical Center in Detroit, Michigan reported that their analysis of data from the Womens Health Initiative showed that women who used oral contraceptives were less likely to develop cancer or cardiovascular disease. The high profile of the Womens Health Initiative, the largest-ever clinical trial of womens health and hormones, lent credibility to this report, which otherwise should have been considered speculative and preliminary,explains Pearson. The report was based solely on abstracts with no published paper to back up the authorsconclusions. Yet the story was reported widely in the following days and weeks.
Key leaders of the Womens Health Initiative have now revealed that the Wayne State report was wrong. Dr. Jacques Rossouw, WHI program officer, in an interview with the London Times, published November 27th, said that The researchers just looked at baseline data, which is very poor data. That is why the findings are so bizarre. These kinds of results are just not credible. Weve asked them to retract it, but its up to them. Dr. Victorys access to WHI data was authorized by a co-author on the report, Dr. Susan Hendrix. Other than Hendrix, there is no connection between the Wayne State report and the WHI, and it was apparently not reviewed by WHI before being presented by Dr. Victory. WHI investigators are meeting in Washington, DC on December 2 and 3 , with Dr. Ross Prentice, from the WHI coordinating center in Seattle, scheduled to present a new analysis, on Thursday, of the information used for the Wayne State report. The meeting will take place at the Marriott at Metro Center.
The WHI included both a randomized trial, the gold standard in research, and an observational study, a significantly lower level of evidence. Victorys report was based on questionnaires given to women participating in the observational arm of the WHI, which included only three or four questions about oral contraceptives. Most epidemiologists believe that this type of study, which questions volunteers about medicines taken as long 30 years earlier, is subject to "recall bias" and is inherently too weak to draw reliable conclusions from.
In addition to criticizing the scientific methods of the study, Pearson questions why Victory and the Wayne State group rushed to publicize these superficial results, drawn from an inherently weak source and without the benefit of internal WHI review. At least two of six co-authors are known to have recent financial connections with Organon, which manufactures the oral contraceptives Desogen and Mircette, as well as the Nuva Ring, a contraceptive device which releases hormones. For example, in 2003 Dr. Susan Hendrix accepted a $132,000 grant from Organon and Dr. Michael P. Diamond has been featured as a leading speaker at Organon-sponsored events. None of these financial connections appear to have been disclosed in the public discussion of the oral contraceptive report.
We are deeply concerned that some women who are risky candidates for the Pill, including those who have had hormone-dependant cancers, strokes, heart attacks, or blood clots may be going on the Pill in the unlikely hope that it might actually protectthem, as Dr. Victory has claimed, says Barbara Seaman, NWHN co-founder. His conclusions fly in the face of most prior oral contraceptive studies and now we know theyre wrong. Women should understand that there were no clinical trials on birth control pills performed under the auspices of WHI. Dr. Victory, who has no formal affiliation with the Womens Health Initiative, presented a report based on questionnaires that dont have a lot of scientific weight. In contrast, the gold standard, randomized, controlled clinical trials, where WHI compared HRT and placebo users, meet the highest scientific standards. We continue to be strong supporters of the WHI and the results that have been reported from the controlled clinical trials.
The National Womens Health Network (NWHN) improves the health of all women by developing and promoting a critical analysis of health issues in order to affect policy and support consumer decision making. NWHN was founded in 1975 to give women a greater voice in the health care system. It is supported by a national membership and does not accept financial support from pharmaceutical companies, tobacco companies or medical device manufacturers.
Barbara Seaman is a co-founder of NWHN and an author whos most recent book on hormones is The Greatest Experiment Ever Performed on Women: Exploding the Estrogen Myth.
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