Disturbing Study Shows Spin and Bias Influence on Outcome of Clinical Breast Cancer Trials

Leslie Carol Botha: The obvious question is – if ‘spin and bias’ exist in the outcomes of breast cancer trials… what other trials are also affected? Hmm. The clinical trials on any and all synthetic hormones comes to mind…. and let’s see we know that spin and bias and deception actually riddle the FDA and Merck reports on the HPV vaccine Gardasil. All one has to do is research – much of which is posted her – to find out that these tactics were used to fast-track the vaccine on to the market.

But think of how many women underwent breast cancer radiation, chemo therapy and surgery based on clinical outcomes that were biased to meet pharma and the medical industries goals.

Spin and Bias in Published Studies of Breast Cancer Trials

Jan. 10, 2013

Spin and bias exist in a high proportion of published studies of the outcomes and adverse side-effects of phase III clinical trials of breast cancer treatments, according to new research published in the cancer journal Annals of Oncology on
January 10.

In the first study to investigate how accurately outcomes and side-effects are reported in breast cancer trials, researchers at the Princess Margaret Cancer Centre and University of Toronto (Toronto, Canada) found that in a third of all trials that failed to show a statistically significant benefit for the treatment under investigation, the reports focused on other, less important outcomes in order to influence positively the interpretation of the results.

In two-thirds of the reports there was bias in the way adverse effects of the treatment were reported, with more serious side-effects (those with toxicities graded as III or IV) poorly reported. This was particularly the case in trials that showed a significant benefit for the treatment under investigation. Only 32% of articles gave details of the frequency of grade III or IV toxicities in the summary (known as the “abstract”).

The authors of the study call for authors, journals and experts who review the articles for journals to be more rigorous in encouraging unbiased reporting of trial results and in enforcing guidelines.

Professor Ian Tannock, medical oncologist and senior scientist in the Division of Medical Oncology and Hematology at the Princess Margaret, who led the research, said: “Better and more accurate reporting is urgently needed. Journal editors and reviewers, who give their expertise on the topic, are very important in ensuring this happens. However, readers also need to critically appraise reports in order to detect potential bias. We believe guidelines are necessary to improve the reporting of both efficacy and toxicity.”

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.