TUGAS KELOMPOK GENAP 4EB10
Nama Kelompok :
1.
Aida Fitriah (20212497)
2.
Esty Putri Ratnasari (22212566)
3.
Risda Aditya (26212453)
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.
