[Music]
one three dimethyl xanthine one three
that methyl xanthine that doesn’t sound
like something you want in your body
what did you have for breakfast oh one
three mess was anything over pancakes
scrambled eggs well I had it in my body
I had into my body you see a while ago
when I was younger I was in graduate
school and I needed some money so what
do you do you need money you’re a young
man in graduate school you’re enrolled
in a clinical trial that’s what I did
and they put a catheter in my arm and
they put this one three dive man throws
anything into my veins yeah
I didn’t I had no idea what 1/3 thought
meant the same thing was but they did
tell me what they were trying to do was
figure out how long it would stay on my
body so that’s what we did we sat around
and we waited for this stuff to get out
of my body now what I didn’t tell you
though was that 1/3 that methyl xanthine
is a cousin biochemically to caffeine a
thousand times more potent than caffeine
so I got this injection on a Friday
afternoon at around 2:00 o’clock I went
to bed Tuesday morning at 4:00 because
of the caffeine so now we know how long
1/3 that methyl xanthine will stay in at
least one body well that was a clinical
trial that used many subjects just like
me to understand the biochemistry of
this particular medication and we didn’t
know what it was but we did know that we
had to find out what this answer was so
what I’m going to talk to you today
about is how we can collectively help
cure disease now if I told you that the
cure to cancer was in your body would
you give it to me would you give it to
your grandma would you give it to your
granddad would you give it to somebody
you didn’t like I didn’t know didn’t
care about that didn’t give you pancakes
would you give it to them I would if I
had the cure to cancer in my body I’d
give it to everybody that’s what this
talk is about crowdsourcing the cures
the cures to cancer and many other
diseases so we’re gonna talk about
clinical trials today and that’s first
thing I’d like to tell you is that we’ve
done clinical trials before we have a
lot of information that we got from
clinical trials and here’s some of it so
moderate alcohol consumption turns out
is good for your heart
who knows clinical trial told us that
blood pressure increases high blood
pressure increases
risk of heart attacks and stroke
clinical trials told us that the
increase of that healthy cholesterol
that they call l h LD that cholesterol
well it reduces the risk of
cardiovascular disease clinical trials
told us this and here’s one that
clinical trials we probably didn’t need
a clinical trial for that but it told us
that smoking was bad for you if you
smoke stop if you don’t smoke don’t
start clinical trials told us that too
and leafy green vegetables are good for
your brain your brain loves that stuff
and the last one I tell you about is
that exercise we know exercise helps
everything it makes you thinner it makes
you more beautiful it grows hair i’ll
trial haven’t quite got there yet all of
this came from clinical trials and this
is probably your image of a clinical
trial but what if i told you that this
was the image of a clinical trial where
you have patient or what we call
participants subjects working
individually with their doctor with the
principal investigator of that clinical
trial we call them P eyes this is a more
accurate vision of what clinical trials
are this is certainly what I experienced
and studies have shown that people in a
clinical trial get the best care they
get care that’s better than anyone else
because they have a team of doctors and
physicians and clinicians working with
them well I want to tell you about what
clinical trials are and how they are put
together they are essentially put into
three broad categories and we call them
phases and each phase is designed to
answer a specific question so phase one
as this question is it safe now that’s a
scary part for most people but let me
tell you before they can put anything in
a human it’s already been gone through
it has gone through many preclinical
tests to identify its safety profile so
this question really is if it is it as
safe as we think it is that’s what this
question is so phase one answers this
question is it as safe as we think it is
when that answer is yes the next
question is in Phase two of the clinical
trial does it work so we think it’s
going to do this we’re gonna shut down
this biochemical pathway which will
starve the tumor of nutrients it needs
and the tumor will die does it really do
that stage two helps us do that then the
last one is phase 3 is it better than
what we’re using already
that’s what phase 3 does and when they
do phase 1 trials they use a few people
they use phase TrueType trials they use
more people and then phase 3 trials or
masses of people that’s where you and I
come in phase 3 trials is it better than
what we’re using already well you have
these 3 phases phase 1 is it safer than
what we think it is phase 2 does it work
better than what we have in phase 3 is
it better than what we have now you
might think that doctors can do this
research all by themselves just hang out
their shingle put on the white coat and
go to town but it’s a little different
than that from that they have some
regulatory controls that are put on them
and it comes in the form of the
institutional review board every phase
of a clinical trial has to have the
management of a institutional review
board to make sure they have one goal
and that’s to make sure that patients
are protected that’s the only goal of
the institutional review board now you
may think that it’s just a bunch of
doctors who are kind of chummy with each
other and they’ve taken care of each
other you’ve approved my trial I’ll
approve yours yeah no no the
institutional review board is made up of
individuals just like you and me patient
advocates sure there are doctors there
but there are patient advocates
sometimes there are patients on these
institutional review boards and everyone
in this room can qualify to sit on an
institutional review board one of the
things that they take care of is this
integrity of the research to make sure
that all of the different components
that leads into patient safety is
maintained in the control in the trial
so this is how they do that
first they have the informed consent the
informed consent simply means that
anyone considering enrolling in a
clinical trial
they must be educated about every
potential problem with that trial
everything that’s going on in that trial
everything that’s going to happen to
them for them and because of them has to
be in that consent form and people just
like you review that consent form and
say yeah this meets our standards
everyone in a clinical trial gets the
standard of care because remember
they’re comparing is it better than what
we have already so if you eat broccoli
to cure the cold and you’re in a
clinical trial guess what they’re gonna
feed you broccoli too along with what
they think is gonna cure the common cold
that’s the standard of care and
everybody gets that there’s also a risk
benefit analysis and that’s where you
take into account the risk of been in a
clinical trial because yes there are
some unknowns against the benefit of
being in that clinical trial and you
have to array that so clinical trial is
a part of the continuum of discovery
once we find a drug that works in the
laboratory we need to test that thing in
people first would a few then a little
more and then a little more I say that
the answer to this cancer problem is in
this room in somebody’s body in all of
our bodies but we need to be part of a
clinical trial so that they can find it
one of the other things with the
clinical trial to make sure that
everybody has the role to participate if
you can want to participate you should
be able to so that we don’t have
clinical trials that look like this one
type of person in the whole trial well
people are different give you an example
when I get a headache I take
acetaminophen when my wife gets a
headache
she takes ibuprofen ibuprofen does
nothing for my headache but it works
great for her we are different in that
way so we’re different in that way
imagine how different we are when it
comes to cancer therapy some of the most
complex diseases on the planet we could
be very different and we may never know
it
we don’t participate in clinical trials
remember that one three that methods
anything this is what came from the
study I was in the dose the dose must be
individualized on the basis of serum
concentration measurements in order to
achieve a dose that will provide the
maximum potential benefit with minimal
risk of adverse events what that really
means is the dose is not a
one-size-fits-all that you have to check
this thing to make sure it’s the right
dose for the right person and now I can
tell you what one three dimethyl the
same thing is you don’t put it on your
pancakes you breathe it
it is a asthma medication for kids a
pediatric asthma medication and now they
know that the dose is not a one size fit
all for every child I help them find
that so when that single parent is
laboring over her child who scratch it
out and labor and trying to get that
next breath or sweet oxygen that we all
love and they’re trying to get it they
give their child one three dimethyl
anything I like to think a night that
there’s somebody’s may be a single
parent who says this is the miracle drug
I have to find out what this drug is
they go to their medicine cabinet and
they take this drug and they read it
they read the label what they see is not
gonna be my name it’s gonna be one three
that methyl xanthine the dose must be
individualized that’s my claim to fame
because I was in a clinical trial before
I go is one thing I want to do I want to
take issue with the term that we use
when someone dies from cancer we often
say that they lost their battle with
cancer the people I know had cancer went
to work they started educating people so
that no one else would have to suffer
with the disease like they did they go
to work to make sure that there’s
funding for research they go out there
and start talking about clinical trials
and the benefits of participating in my
view that’s not losing the bad
thanks to some of the people I’ve known
who’ve gone on millions of people
understand the risk of breast cancer and
those are just the ones that I know
that’s not losing the battle in my mind
they’re passing the torch they passed
the torch to me and they passed the
torch to you and they’re going down the
only way that we can thank them the only
way that we can move progress forward is
to participate in the clinical trial
continuum maybe being a patient is not
for you but being on that institutional
review board could be so the next time
someone asked you what you want in your
pancakes tell them 1 3 dimethyl xanthine
thank you everybody
thank you
[Applause]
[Music]
one three dimethyl xanthine one three
that methyl xanthine that doesn’t sound
like something you want in your body
what did you have for breakfast oh one
three mess was anything over pancakes
scrambled eggs well I had it in my body
I had into my body you see a while ago
when I was younger I was in graduate
school and I needed some money so what
do you do you need money you’re a young
man in graduate school you’re enrolled
in a clinical trial that’s what I did
and they put a catheter in my arm and
they put this one three dive man throws
anything into my veins yeah
I didn’t I had no idea what 1/3 thought
meant the same thing was but they did
tell me what they were trying to do was
figure out how long it would stay on my
body so that’s what we did we sat around
and we waited for this stuff to get out
of my body now what I didn’t tell you
though was that 1/3 that methyl xanthine
is a cousin biochemically to caffeine a
thousand times more potent than caffeine
so I got this injection on a Friday
afternoon at around 2:00 o’clock I went
to bed Tuesday morning at 4:00 because
of the caffeine so now we know how long
1/3 that methyl xanthine will stay in at
least one body well that was a clinical
trial that used many subjects just like
me to understand the biochemistry of
this particular medication and we didn’t
know what it was but we did know that we
had to find out what this answer was so
what I’m going to talk to you today
about is how we can collectively help
cure disease now if I told you that the
cure to cancer was in your body would
you give it to me would you give it to
your grandma would you give it to your
granddad would you give it to somebody
you didn’t like I didn’t know didn’t
care about that didn’t give you pancakes
would you give it to them I would if I
had the cure to cancer in my body I’d
give it to everybody that’s what this
talk is about crowdsourcing the cures
the cures to cancer and many other
diseases so we’re gonna talk about
clinical trials today and that’s first
thing I’d like to tell you is that we’ve
done clinical trials before we have a
lot of information that we got from
clinical trials and here’s some of it so
moderate alcohol consumption turns out
is good for your heart
who knows clinical trial told us that
blood pressure increases high blood
pressure increases
risk of heart attacks and stroke
clinical trials told us that the
increase of that healthy cholesterol
that they call l h LD that cholesterol
well it reduces the risk of
cardiovascular disease clinical trials
told us this and here’s one that
clinical trials we probably didn’t need
a clinical trial for that but it told us
that smoking was bad for you if you
smoke stop if you don’t smoke don’t
start clinical trials told us that too
and leafy green vegetables are good for
your brain your brain loves that stuff
and the last one I tell you about is
that exercise we know exercise helps
everything it makes you thinner it makes
you more beautiful it grows hair i’ll
trial haven’t quite got there yet all of
this came from clinical trials and this
is probably your image of a clinical
trial but what if i told you that this
was the image of a clinical trial where
you have patient or what we call
participants subjects working
individually with their doctor with the
principal investigator of that clinical
trial we call them P eyes this is a more
accurate vision of what clinical trials
are this is certainly what I experienced
and studies have shown that people in a
clinical trial get the best care they
get care that’s better than anyone else
because they have a team of doctors and
physicians and clinicians working with
them well I want to tell you about what
clinical trials are and how they are put
together they are essentially put into
three broad categories and we call them
phases and each phase is designed to
answer a specific question so phase one
as this question is it safe now that’s a
scary part for most people but let me
tell you before they can put anything in
a human it’s already been gone through
it has gone through many preclinical
tests to identify its safety profile so
this question really is if it is it as
safe as we think it is that’s what this
question is so phase one answers this
question is it as safe as we think it is
when that answer is yes the next
question is in Phase two of the clinical
trial does it work so we think it’s
going to do this we’re gonna shut down
this biochemical pathway which will
starve the tumor of nutrients it needs
and the tumor will die does it really do
that stage two helps us do that then the
last one is phase 3 is it better than
what we’re using already
that’s what phase 3 does and when they
do phase 1 trials they use a few people
they use phase TrueType trials they use
more people and then phase 3 trials or
masses of people that’s where you and I
come in phase 3 trials is it better than
what we’re using already well you have
these 3 phases phase 1 is it safer than
what we think it is phase 2 does it work
better than what we have in phase 3 is
it better than what we have now you
might think that doctors can do this
research all by themselves just hang out
their shingle put on the white coat and
go to town but it’s a little different
than that from that they have some
regulatory controls that are put on them
and it comes in the form of the
institutional review board every phase
of a clinical trial has to have the
management of a institutional review
board to make sure they have one goal
and that’s to make sure that patients
are protected that’s the only goal of
the institutional review board now you
may think that it’s just a bunch of
doctors who are kind of chummy with each
other and they’ve taken care of each
other you’ve approved my trial I’ll
approve yours yeah no no the
institutional review board is made up of
individuals just like you and me patient
advocates sure there are doctors there
but there are patient advocates
sometimes there are patients on these
institutional review boards and everyone
in this room can qualify to sit on an
institutional review board one of the
things that they take care of is this
integrity of the research to make sure
that all of the different components
that leads into patient safety is
maintained in the control in the trial
so this is how they do that
first they have the informed consent the
informed consent simply means that
anyone considering enrolling in a
clinical trial
they must be educated about every
potential problem with that trial
everything that’s going on in that trial
everything that’s going to happen to
them for them and because of them has to
be in that consent form and people just
like you review that consent form and
say yeah this meets our standards
everyone in a clinical trial gets the
standard of care because remember
they’re comparing is it better than what
we have already so if you eat broccoli
to cure the cold and you’re in a
clinical trial guess what they’re gonna
feed you broccoli too along with what
they think is gonna cure the common cold
that’s the standard of care and
everybody gets that there’s also a risk
benefit analysis and that’s where you
take into account the risk of been in a
clinical trial because yes there are
some unknowns against the benefit of
being in that clinical trial and you
have to array that so clinical trial is
a part of the continuum of discovery
once we find a drug that works in the
laboratory we need to test that thing in
people first would a few then a little
more and then a little more I say that
the answer to this cancer problem is in
this room in somebody’s body in all of
our bodies but we need to be part of a
clinical trial so that they can find it
one of the other things with the
clinical trial to make sure that
everybody has the role to participate if
you can want to participate you should
be able to so that we don’t have
clinical trials that look like this one
type of person in the whole trial well
people are different give you an example
when I get a headache I take
acetaminophen when my wife gets a
headache
she takes ibuprofen ibuprofen does
nothing for my headache but it works
great for her we are different in that
way so we’re different in that way
imagine how different we are when it
comes to cancer therapy some of the most
complex diseases on the planet we could
be very different and we may never know
it
we don’t participate in clinical trials
remember that one three that methods
anything this is what came from the
study I was in the dose the dose must be
individualized on the basis of serum
concentration measurements in order to
achieve a dose that will provide the
maximum potential benefit with minimal
risk of adverse events what that really
means is the dose is not a
one-size-fits-all that you have to check
this thing to make sure it’s the right
dose for the right person and now I can
tell you what one three dimethyl the
same thing is you don’t put it on your
pancakes you breathe it
it is a asthma medication for kids a
pediatric asthma medication and now they
know that the dose is not a one size fit
all for every child I help them find
that so when that single parent is
laboring over her child who scratch it
out and labor and trying to get that
next breath or sweet oxygen that we all
love and they’re trying to get it they
give their child one three dimethyl
anything I like to think a night that
there’s somebody’s may be a single
parent who says this is the miracle drug
I have to find out what this drug is
they go to their medicine cabinet and
they take this drug and they read it
they read the label what they see is not
gonna be my name it’s gonna be one three
that methyl xanthine the dose must be
individualized that’s my claim to fame
because I was in a clinical trial before
I go is one thing I want to do I want to
take issue with the term that we use
when someone dies from cancer we often
say that they lost their battle with
cancer the people I know had cancer went
to work they started educating people so
that no one else would have to suffer
with the disease like they did they go
to work to make sure that there’s
funding for research they go out there
and start talking about clinical trials
and the benefits of participating in my
view that’s not losing the bad
thanks to some of the people I’ve known
who’ve gone on millions of people
understand the risk of breast cancer and
those are just the ones that I know
that’s not losing the battle in my mind
they’re passing the torch they passed
the torch to me and they passed the
torch to you and they’re going down the
only way that we can thank them the only
way that we can move progress forward is
to participate in the clinical trial
continuum maybe being a patient is not
for you but being on that institutional
review board could be so the next time
someone asked you what you want in your
pancakes tell them 1 3 dimethyl xanthine
thank you everybody
thank you
[Applause]
[Music]
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