Bazell, R. (1998). "Her-2: The Making of Herceptin". New York: Random House.
In his interesting and insightful account of “the making” of Herceptin, Robert Bazell, shows how the creation of a new drug is not only a scientific process, but also a social endeavour involving patients, doctors, regulators, funders, politicians, activists and the media. This is particularly so when it comes to clinical trials for a new product, and Bazell’s description of this procedure for Herceptin (Trastuzumab) is detailed and would form an excellent resource for illustrating its complexities and/or discussing its complications.
While the book deals with much more than the clinical trials of Herceptin – including the sources of early interest in the Her-2/neu receptor in breast cancer and the collaborations that eventually brought the potential of this monoclonal antibody to the attention of Genentech’s management – this post focusses on the clinical trials that formed the basis for its licensing by the FDA (Food and Drug Administration) in the US and subsequent worldwide use as an adjuvant therapy in advanced (metastatic) breast cancer.
This post is accompanied by a BioethicsBytes Extended Commentary on the making of herceptin (available here), which discusses some additional bioethical issues raised in this post.
Read the rest of this entry »
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BioethicsBytes
Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer – Bazell (1998)
September 4, 2008Bazell, R. (1998). "Her-2: The Making of Herceptin". New York: Random House.
In his interesting and insightful account of “the making” of Herceptin, Robert Bazell, shows how the creation of a new drug is not only a scientific process, but also a social endeavour involving patients, doctors, regulators, funders, politicians, activists and the media. This is particularly so when it comes to clinical trials for a new product, and Bazell’s description of this procedure for Herceptin (Trastuzumab) is detailed and would form an excellent resource for illustrating its complexities and/or discussing its complications.
While the book deals with much more than the clinical trials of Herceptin – including the sources of early interest in the Her-2/neu receptor in breast cancer and the collaborations that eventually brought the potential of this monoclonal antibody to the attention of Genentech’s management – this post focusses on the clinical trials that formed the basis for its licensing by the FDA (Food and Drug Administration) in the US and subsequent worldwide use as an adjuvant therapy in advanced (metastatic) breast cancer.
This post is accompanied by a BioethicsBytes Extended Commentary on the making of herceptin (available here), which discusses some additional bioethical issues raised in this post.
Read the rest of this entry »