Today I examine a company who not only serves as an example of the ethical imperative in the structure and design of a business, but I may even be able to forecast a crisis in the making. Most case-studies of crises occur after a crisis has ended or at least after it has begun, but the actions of the pharmaceutical company BioMarin over the last several weeks – while not reaching crisis yet – are moving quickly in the direction of one.

The background of the story is that BioMarin has created a drug called BMN673 that has not yet been approved by the Food and Drug Administration (FDA), but which has shown enormous promise to patients who have gone through trials of the drug. Between 5-10% of ovarian cancer patients develop the cancer due to a genetic mutation called BRCA1. This drug was created for that rarer set of ovarian cancer patients. Creating drugs for rarer diseases is BioMarin’s specialty.

A young attorney in Austin, Texas named Andrea Sloan has the BRCA1 mutation and has fought ovarian cancer off and on since 2007. Traditional treatments are failing at this point, and Andrea’s doctors at MD Anderson view BMN673 as Andrea’s best and possibly last hope.

By what ethical standard can BioMarin continue to deny Andrea Sloan this drug which she must get within the next several days? A moral imperative should supersede a financial one when a person’s life is on the line, but how would BioMarin even face a financial risk in allowing this compassionate use of their innovative drug?

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