publication date: Apr. 3, 2015

Resolving Disputes in Precision Medicine: The Question of CYP2D6 Remains Open


What does it take to declare that a scientific dispute is resolved?

A long-running argument over the role of a biomarker in the treatment of breast cancer illustrates a challenge that runs through the heart of precision medicine: the absence of mechanisms for resolving disagreements between scientists.

The story of CYP2D6, a mutation that may (or may not) predict the manner in which the patient metabolizes the cheap, widely used drug tamoxifen, is of the sort that makes insiders shake their heads.

The question is relevant to an estimated 150,000 newly diagnosed estrogen receptor-positive breast cancer patients a year in the U.S. alone.

The controversy is more important than CYP2D6, tamoxifen and breast cancer. The same questions have to be answered as Food and Drug Administration and the Centers for Medicare and Medicaid Services establish validity and decide on coverage of biomarker tests.

Is anyone—the academic journals, government agencies or private payers—capable of resolving controversies over the role particular biomarkers play in disease? The Cancer Letter asked a group of experts to answer this question. Their answers appear on page 9.

Here is how the controversy has played out in the context of CYP2D6:

In December 2010, at the San Antonio Breast Cancer Symposium, two groups of researchers presented separate analyses of tissues obtained in two large randomized clinical trials, the Breast International Group 1–98 (BIG 1–98) and the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial.

Both groups … Continue reading 41-13 Resolving Disputes in Precision Medicine: The Question of CYP2D6 Remains Open

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