September 4, 2008
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.
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January 10, 2008
This episode of the BBC current affairs series Panorama follows the story of seven women with breast cancer who campaigned to receive the drug Herceptin. It is a classic example of the tensions arising from the rise in effective but expensive new medicines set against the constrained budget of the National Health Service. At the time of filming (Summer/Autumn 2005), treatment with Herceptin cost £30,000 per patient per year and was exclusively licensed for use against advanced-stage breast cancer. However in light of some promising and well-publicised clinical trials, and motivated by Prime Minister Tony Blair’s pledge that “Cancer patients in all parts of the country will get the right drugs at the right time, regardless of where they live” (00:02:50-00:03:10), seven women with early-stage breast cancer believed that this drug may well help save their lives. The programme follows their campaign as it snowballs from a local issue to achieve national support (00:11:45-00:13:50).
The central ethical question raised by this programme is, therefore, one of resource allocation. There is a cost-benefit analysis to be done for the treatment per se, but this also has to be seen in a broader context; a decision to fund one therapy means a decision elsewhere in the system that likely denies somebody the treatment that they want. How do you evaluate one course of treatment over another? How do you fairly distribute public resources between patients? Can you judge the value of one life against another? Read the rest of this entry »