Case
Analysis
The
Betaseron Decision
This case is about the
dilemma Betaseron had over their MS treating medicine that was under extremely
high demand but they were not able to fulfill all demand for the first 2 years.
Betaseron is proven to greatly improve the quality of life for people with MS
and is therefore under high demand. But due to the low production rates and the
fact that Betaseron was unprepared to manufactured and distribute the medicine,
it was estimated that they would have enough of it for less than 1/5 of the
potential client base. This created the dilemma of who would receive the
medicine and who would have to wait, among many other problems.
Even though there are many
issues with the distribution and manufacturing of Betaseron, this is not the
major problem. There is one major problem that lead to all this chaos and rush
and that is the fact of how the FDA decided to expedite the approval process
for Betaseron. This took one year instead of the standard three. Betaseron was
not expecting this, the therefore had to dramatically upscale production and
start to distribute the medicine in a relatively short amount of time. This lead
to many other problems, such as who would get the medicine and who would have
to wait. If Betaseron would have had the additional 2 years they had
anticipated to get the medicine into production and distribution.
Analysis :
Betaseron, Chiron Corporation,
and Berlex Laboratories all did the best things they could under the possible
circumstances. They were anticipating a 3 years FDA approval process, which
would have allowed them the time necessary to put Betaseron in production and
distribution. Betaseron was the first and only drug that was proven to have an
effect on the frequency of exacerbations. Therefore, Chiron Corporation had an
extreme amount of pressure from people with MS and organizations supporting the
research of MS to get the medicine out on the market and helping people as soon
as possible, even if it would mean having to choose only select patients. Betaseron
was greatly improving the quality of life for about 12.000-20.000 people in its
first year of production (by the end of 1993). And they estimated that in 1996
they would be able to provide it to all who requested the Betaseron. So even
though they are not able to fulfill all demand in the first 2 years, they are
helping people 2 years earlier then they would have been able to do if the FDA
would have taken the customary 3 years to approve Betaseron. Overall, Betaseron
did the best thing they could have done in the available circumstances.
Nama Kelompok 4EB10 :
1.
Aida Fitriah (20212497)
2.
Esty Putri Ratnasari (22212566)
3.
Risda Aditya (26212453)
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