Krall Examines the Ethics of Experimental Medicine

Ron Krall, a senior vice president in worldwide development at GlaxoSmithKline, spoke Friday about pharmaceutical ethics, particularly giving patients access to experimental medication outside of clinical trials. Krall, who was a math major in the class of 1969, did not use a traditional lecture format; instead, he led a discussion, even putting his personal email up on the board for “those of you who aren’t satisfied” by the necessarily brief discussion.

The lecture was based on a case study, in which a father requests an experimental medication for his 21-year-old daughter Amanda, who has terminal head-and-neck cancer. The medicine is currently in testing for lung cancer treatments; it seems likely, however, that it would work well for head-and-neck cancer. The drug works by suppressing epidermal growth factor receptors (EGFRs), which present in both lung cancer and head-and-neck cancer.

It would seem only natural to give Amanda the drug: if it did something bad to her, so what? She was going to die soon anyway. Indeed, when polled before the discussion most of the students were relatively sure that Amanda should be given the drug. On the other hand, if something bad did happen, then it would almost certainly interfere with the approval process for the drug, which — if all goes well — would otherwise be available to regular patients within about three years.

Even if the treatment works well, though, word will spread about how this medicine helped Amanda; other patients will demand it as well, and how could the company justify giving the drug to some patients but not others? Furthermore, giving the drug to Amanda would undermine the company’s ability to perform clinical trials for treating head-and-neck cancer. Clinical trials, to be meaningful, require a control group, but who would be willing to have a fifty-fifty chance of getting medication when they know that other patients were just given the drug?

In the end, the actual doctor decided not to give Amanda the medication. As Krall said, “We want medicines with benefits greater than harms, and we want those decisions to be based on evidence.” Unfortunately, in order to reach that goal, “we often have to be in a very unsatisfying place.”


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    Andrew Rugg says:

    In the meantime, let the Amandas of the world with terminal head and neck cancer be damned. Likewise, let the Andrews of the world with terminal lung cancer be damned, as well. That is why I have total contempt for the current method the evil FDA has to approve drugs. What kind of gods do they think they are to say who (like myself) must die so that others might live. That decision should belong exclusively to the Amandas and the Andrews of the world, definintely not to the FDA and the pharmeceutical companies. After all, it is Amanda’s life as it is my life that is on the line, not the lives of the COB of GlaxoSmithKline or the Administrator of the FDA that they are thinking about sacrificing.

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