Blue Promise: Understanding the Evolution of Pharmaceuticals

[Music] DAN: We are
Blessed here in the
United States to have very safe
medications but how do drugs
get approved? Hello I’m
Dr. Dan McCoy and welcome to
this episode of Blue Promise I’m here
Today with Lisa McCormack
who’s our director of pharmacy at
Blue Cross And Blue Shield
of Texas Lisa welcome
to Blue Promise LISA: Thank you DAN: Okay so tell me
who’s in charge of making sure that our
drugs are safe? LISA: The FDA is
in the United States who we rely on to
ensure that drugs are one safe and
that they’re efficacious and work
in the population designed for DFAN: So that’s
the food and drug
administration LISA: correct the
Food and Drug Administration DAN: Government
Agency? LISA Yes DAN: Okay but
this government agency doesn’t
actually do the research and that
sort of thing right So tell me how
that process work If somebody comes
up with a great idea say to cure cancer
or treat high blood pressure how does
that drug go through the process? LISA: So pharmaceutical
companies in the United States typically
are the brainchild behind the development
of a drug and they oftentimes will market
and research several drugs at one time
At that point in time they have to go
through multiple clinical trials
starting in like Phase one
Clinical trials In each phase
they have to include more
members and look at additional measures
so they might start just looking at
safety and end up having to prove
that it works and once they have completed
those trials then that is what is presented
to the FDA or Food and Drug Administration
for review DAN: And then the FDA
gets to make a decision about whether or not
the drug is released into the
market LISA: Correct DAN: Or not so the first
part of that research the phase we´┐Żll say
one two and three for practical
discussion those are closed
right so doctors can’t really write prescriptions for those drugs
those are that’s a research
study LISA: Yes occasionally
you will see phase 2 trials being considered
in Oncology and some very rare conditions that you
may end up seeing those used in study references
or purposes but typically they have to go through
to the open trials DAN: And I would expect
that that process is long and to some degree
expensive which may be one of the contributors
to drug costs LISA: Correct and the
faster than the number of drugs that they don’t
get approved that they study which I hate to
say does impact drug costs because it’s
an investment the pharmaceutical company
has made DAN: Cause I guess
they’re going through the process to determine
safety and efficacy and it may not be safe
and may not work all right? LISA: Correct DAN: Okay so now the
Story goes that they get the drug approved but
I take it that really the story doesn’t stop there righ
1 because what happens after a drug gets to marke
and a little bit about how did the study
continues LISA: oftentimes after
a drug makes it to market they’ll continue
looking at what they call post marketing evaluation
for safety and efficacy that’s where sometimes
you will see spikes and something especially in
small populations that may not have been present in
the trial but all of a sudden side effects are
present or new drugs come to the market and
now there’s new drug interactions that they didn’t
1necessarily consider so at that point in
time typically you can see recalls
in the car you can see changes
in their indications occur over the course
of time based on that DAN: and that really
shouldn’t surprise people right because
I mean that’s happened before right in history
where drugs have been released and they’ve
been recalled or taken off the
market LISA: correct when they
go out into the general population and you have so
many people taking it there may be a new side
effect that wasn’t seen in the trials that occur
in the past there’s an arthritis medication that
comes to mind that showed some effects cardiovascularly and they had to pull it
back off the market DAN: Well Lisa this has
been very helpful and thanks for bein
here today and Thanks for joining
us for this episode of Blue Promise LISA: Thank you DAN: Thank you [Music]

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