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Monday, March 20, 2006

The Impact of Pre-Publication Presentation of Results: Epi Inquiry Accolade 03/20/2006

[Epidemiologic Inquiry 2006, 1: 21]

When is it a good idea, and when is it a bad idea to announce scientific results before formal publication? Does the medical community and the public quickly adopt pre-publication findings even though the results are not yet peer-reviewed? Such were the questions address by the recent article in JNCI by Giordano et al. and its accompanying editorial by Woloshin and Schwartz.

Giordano et al. investigated whether a new taxane treatment for lymph-node positive breast cancer significantly increased after its efficacy results were reported at the May 1998 meeting of the American Society of Clinical Oncology. Even though the taxane was not yet FDA approved and the formal publication was not to appear until 5 years later, the authors found that use of the newly reported treatment significantly increased >400% overall after the conference report. Furthermore, even though the treatment was shown only efficacious in lymph-node positive breast cancers (use increased 800%), results also showed that its use in patients with lymph-node negative breast cancers also increased 300%, which is in fact quite clinically disturbing as the drug was not even shown efficacious for such a disease.

The accompanying editorial by Woloshin and Schwartz summarized the risk and benefits of early adoption of pre-publication results, as well as noted examples in which early adoption has been clinically detrimental. Notably, the drug gefitinib (Iressa) had once been granted early FDA approval for increasing survival of patients with non-small-cell lung cancer who failed chemotherapy, even though the trial was unpublished, was a single uncontrolled trial, and subsequent issues were raised regarding adverse pneumonia deaths. Though over 200,000 people used the drug by 2004, a subsequent placebo-controlled trial shows no increased survival benefit. Such is an example in which adoption of pre-publication results did not benefit the public, and may have in fact caused more harm.

Woloshin and Schwartz summarize the following set of guideline regarding when to potentially adopt any pre-publication results:
1) large difference in all-cause mortality
2) no adverse effects
3) results are from a large randomized trial with long duration
4) confirms prior trial results, or presents first randomized trial evidence
5) no alternative treatments exist

For highlighting such important issues, the editors select as the dual-Epidemiologic Inquiry Accolade: Investigation of the Week...

Giordano SH, Duan Z, Kuo YF, Hortobagyi GN, Freeman J, Goodwin JS. Impact of a scientific presentation on community treatment patterns for primary breast cancer. J Natl Cancer Inst. 2006 Mar 15;98(6):382-8.

Woloshin S, Schwartz LM. What's the rush? The dissemination and adoption of preliminary research results. J Natl Cancer Inst. 2006 Mar 15;98(6):372-3.

~The Editors

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