Case 18: The Betaseron® Decision (A)
1. What are the ethical issues in this situation? Which issues must Berlex consider first when
determining how to distribute Betaseron®?
Is Berlex or Chiron at fault for not being able to meet the demand for a drug that they are
marketing and manufacturing, or did they have no way of knowing that the FDA would expedite
approval of Betaseron®? If the FDA did not let Berlex and Chiron know of the expediting of
supply to a group too large to be satisfied by that supply?
2. Given the shortage of the drug, how should Berlex decide who receives it and who waits?
Give a specific plan.
By deciding that one subgroup or another of the pool of potential recipients is to receive
Betaseron® before another, Berlex would have to make the difficult decision of whose needs are
3. How should Berlex handle the logistics of distribution?
Any system must ensure that every patient will receive the full dosage needed, because the
treatment is not effective if not followed carefully. One potential problem, due to the shortage, is
that there will be a scramble for the drug—leaving no one with a full treatment regimen.
Somehow distribution must be controlled to account for this possibility. In addition, the markup
from pharmacies can add significantly to the cost of an already expensive drug. Ways to
minimize the cost to the patient should also be considered.
4. How should Berlex determine the drug’s relative pricing? Assume the drug costs about
$12,000 per year.
Should the price of the drug be dependent upon a patient’s ability to pay? How does insurance
coverage factor in? Students should be pushed to consider the implications of each of their
suggestions. They do not have enough information to determine the appropriate price. However,
they can determine how the price would differ between individuals, knowing that a price
reduction for one means an increase in price for another. They should also consider insurance
5. Who, if anyone, should be involved in the decision making?
Concerning distribution, if Berlex decides to use the lottery method, nobody is actually involved
in the decision (it is a random distribution). The FDA should be involved, since it conducted the
tests of Betaseron® and best knows the results concerning which MS patients will and will not