publication date: Apr. 3, 2015
A Biomarker Court? Who Should Decide?
No pharma company is clamoring to get a response to the question of significance of CYP2D6.
Since an estimated 7 percent of newly diagnosed breast cancer patients are poor metabolizers of tamoxifen, perhaps as many as 93 percent are good candidates for receiving this cheap generic drug.
If the pro-CYP2D6 wing is right, the market for an entire class of drugs—aromatase inhibitors—would shrink dramatically. AIs are also available in generic form, but are typically more expensive than tamoxifen.
“A fundamental responsibility of FDA is looking at safety and efficacy of treatments,” said Gregory Curt, executive director for external scientific and medical relations at AstraZeneca. “Would the agency want to weigh in on this discussion? They do have national reach, after all.”
To act, FDA needs data. Alas, it cannot force anyone to produce data, especially in a situation where there is no eager sponsor who would be willing to launch clinical trials.
The Cancer Letter asked a group of experts whether existing mechanisms for resolving scientific disputes have the capacity to handle the tidal wave of questions over validity of biomarkers.
Their answers follow:
Carmen Allegra, chief of the Division of Hematology & Oncology and associate director for clinical & translational research at the University of Florida Cancer Center and editor-in-chief of JNCI:
What role should the scientific journals play in resolving scientific controversies?
As editor-in-chief of the JNCI where most of the controversy surrounding the utility of CYP2D6 has played out, I had an opportunity to consider our role.
… Continue reading 41-13 A Biomarker Court? Who Should Decide?
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