6 - Engineering the clinic – getting personalised medicine into practice

Summary

There's no point in doing diagnostic tests that don't advance your care of the patient; it's a waste of money and it's waste of the patient's time.

(Pharmacist 2)

Herceptin, breast cancer and drugs

If the story so far has been about resistance to personalised medicine, how not to get pharmacogenetics into the clinic, then the next three chapters are an example of pharmacogenetics that did successfully make that move. In 1998 the US Food and Drug Administration (FDA) licensed a new drug called Herceptin. Aimed specifically at women with metastatic (i.e. severe) breast cancer, the drug was rushed through the FDA's licensing procedures using a special mechanism. With little or no effective treatment for this kind of cancer, Herceptin, like so many other drugs, was heralded by the popular press as a breakthrough. Beyond the headlines, it is an extremely interesting drug if you happen to be interested in the way in which pharmacogenetics moves into the clinic, because, depending on who you talk to, Herceptin may just be the first example of a pharmacogenetic drug in regular clinical use.

The story of the development of Herceptin, its shepherding through clinical trials and the internal company politics that almost killed the drug off make a fantastic narrative about the role of the contingent and the social in technoscience. But this is not the story I am going to tell, for two reasons.