Margaret Anderson, Executive Director of FasterCures

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Mark Masselli: This is Conversations on Healthcare I'm Mark Masselli.

Margaret Flinter: And I'm Margaret Flinter.

Mark Masselli: Well Margaret we like to focus on issues of human health on this show
but animal health can often be a cannery in the cold mind and we're watching with some
real concern the expanding outbreak of bird flu in the country.

Margaret Flinter: And several strands of avian flu have shown up across the country.
Now tens of millions of birds have been destroyed, the turkey population especially hard
hit in the Midwest and now egg growers are sounding an alarm.

Mark Masselli: At the moment the outbreak shows no sign of (inaudible 0:34 ) in multiple
poultry species. And it's being monitored very closely by the USDA and the CD C.

Margaret Flinter: Keeping the country's food stream safe and free from harmful
pathogens is a vital public health obligation and really an ongoing challenge for these
federal agencies including the FDA which of course is test with insuring drug safety as
well. Something our guest today is quiet familiar with, Margaret Anderson is the
Executive Director of FasterCures a non - profit that's dedicated to improving drug and
medical research systems to work faster and more efficiently than they have up until
now. She'll talk about how new technologies are poised to accelerate the pace of drug
discovery and development.

Mark Masselli: Lori Robertson checks in, the managing editor of FactCheck.org is
always on the hunt for misstatements spoken about health pol icy in the public domain.
But no matter what the topic you can hear all of our shows by going to chcradio.com.

Margaret Flinter: And as always if you have comments please email us at
[email protected] or find us o n Facebook, Twitter we love to hear from you. We'll get
to our interview with Margaret Anderson in just a moment.

Mark Masselli: But first her is our producer Marianne O'Hare with this week's headline news.

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Marianne O'Hare: I'm Marianne O'Hare w ith these Healthcare Headlines. Florida
Governor Rick Scott sees a state shutdown looming come July 1
st
steadfastly refusing
to expand Medicaid in his state. In spite of warnings from the federal government that
billions of hospital dollars would be lost to the state as a result. Scott has now sent a
memo to all state agency heads making a list of all nonessential expenditures and
warning entire agencies could be shutdown as a result. Scott leading a dwindling pack

of state leaders across the country wh o have refuse to expand Medicaid coverage for
their residence living closer to the poverty line.

A rite of passage for the over 50 crowd colonoscopies are required screenings and have
done much to bring down the death rate from the common form of cancer ot her than the
unpleasant process of the preparation and screening itself under the Affordable Care
Act more Americans are seeking screenings because it's covered. The federal
government decided to remove another barrier to the screening for some, the cost of
anesthesia, some insurers weren't covering that cost. The fed said anesthesia which
often a company's called endoscopies must be covered as well.

California's legislatures passed a bill eliminating personal beliefs as a reason for opting
out and vaccin ating their children. The law restricts families opposed to vaccines for
personal beliefs is not reason enough to put their children and the larger population at
risk for preventable childhood diseases like measles, mumps and rubella. An outbreak
of meas les earlier this year sicken hundreds in California.

The South Carolina self - employed republican oppose to the Affordable Care Act found
himself on the brink of bankruptcy and diabetes related blindness after a series of
strokes caused bleeding in his eyes and his savings were exhausted in the emergency
room treatments. It also left him without enough money and without coverage for the
surgery required to save his eyesight. Though still opposed to the healthcare law he
made a public plea for help. He rec eive generous donations from an interesting source
self described progressives donating thousands to cover his surgery saying they hope
he's learned his lesson. I'm Marianne O'Hare with these Healthcare Headlines.

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Mark Masselli: We're speaking to day with Margaret Anderson, Executive Director of
FasterCures an action tank at the Milken Institute dedicated to removing barriers to
medical progress by speeding up the medical research system. She's the past
president of the alliance of stronger FDA, i s a member of the NIAH National Center for
Advancing Translational Sciences . Previously Ms. Anderson was the Deputy Director in
the Center on AIDS and community health at the Academy for Educational
Development. Ms. Anderson holds a bachelors degree from the University of Maryland
and a master's degree in science technology and public policy from George Washington
University. Margaret welcome to Conversations on Healthcare.

Margaret Anderson : Thank you it's a pleasure to be here.

Mark Masselli: Yeah, a nd you just got back from the Milken Institutes Annual Global
Conference and that's always a great gathering of luminaries and influencers. And I
wonder if you could share with our listener some of the more exciting ideas heard at the

conference, and how do they illustrate the overall mission of the global conference as
well as the mission of the institute?

Margaret Anderson: It's a gathering that brings together over 3000 of the world's
leading visionaries in all different sectors from business and finan ce to government and
that isn't just the United States government but globally. So a lot of discussion about
making the world a better place for women and girls. I worked on the medical research
track and I would say those conversations were clustered ar ound a few main themes.
The elevation of medical research on to the national policy agenda, the second would
be the evolution that we've witnessed of patients roles in the healthcare delivery system
and research system. Next I would say future of precisi on medicine, you know, sort of
solutions oriented nature of that is really emblematic of the Milken Institutes work and
FasterCures and we're a part of that.

Margaret Flinter: I'd like to Margaret maybe focus on your division of FasterCures, it
has a spec ific mission of its own within the context of the larger organization and have
this goal to remove barriers to medical progress by speeding up the medical research
system. What are some of the great challenge has been and why do you think the time
is righ t for revamping the medical and health research process?

Margaret Anderson: So of the 10,000 known deadly and debilitating diseases that
affect the world today, only about 500 of those have effective treatments. We also know
that, you know, bringing any kind of a new therapeutic forward from, you know, the
beginning of discovery in basic science to the market place it takes on average 15 years
over a billion dollars. Just to bring one therapy forward from discovery to patients. So,
you know, Dr. Francis Collins who's the Director of the National Institutes of Health will
say that the paradox here is we're living in this crazy time where there's a scientific
agenda that's catapulting forward with an engine that's kind of running on two little fuel.
I rea lly do think that there's sort of this unique moment that we're looking at where the
scientific promise is accelerating in a pace that I think is staggering. And we need to
make sure the system's ready for it.

Mark Masselli: You laid out some of the grou nd work of this as sort of infrastructure.
Maybe you can talk about this new reality of reduced funding and where opportunities
might lie in terms of a collaborative approach in research?

Margaret Anderson: The NIAH has experienced a gradual lost of its purchasing power.
They're down almost 25% below where they were in the year 2003. So we have this
conundrum here where we are pushing STEM education and we really believe in the
power of science but we're starving it essentially. Right now the NIAH only can fund
roughly one grant out of six which is about half of what they used to be able to fund.
This funding is critical and it's critical because if we starve that scientific enterprise there

will be no cures and treatments to develop. Those philanthro py groups we call them
venture philanthropy, out of that venture philanthropy model we've just seen some
breathtaking advancements come. So it's powerful capital people call it passion capital
but it cannot supplant, you know, the vital role of NIAH.

Margaret Flinter: Well Margaret I wonder maybe just take one more look at this issue of
collaboration. We've entered the new arena of genomics and proteomics in the
expansion of digital technologies and personalized medicine. But I've seen this kind of
parallel wave of innovation around patient engagement certainly through organizations
like patients like me and (inaudible 8:43 ) which i s another way of engaging patients.
How is this advance in collaboration spurring new kinds of developments in biomedic al
research?

Margaret Anderson: You know, if you look at the role of patients overtime I would say
that role has expanded dramatically in the past 40 years. In the 1980s during the
HIV/AIDS, you know, the beginning of the epidemic we witnessed, you know, dramatic
transformation of the biomedical research system. And I would argue also healthcare
delivery by HIV/AIDS activist. They demonstrated that you can bring attention to a
cause but a piece that FasterCures is really try to push forward is that it w asn't just
about public disobedience and demonstrations, it was about getting very smart on the
science. And by getting smart those activist were able to demand change and get
results and we have a paper called back to basics that you can find on our webs ite that
will, you know, kind of characterize this evolution.

So what we see now are patients and organizations representing patients really being
looked at more as partners in, you know, kind of R&D equation. And so you reference
some of the groups like patients like me or smart patients. There's a number of these
types of groups that are allowing patients to engage in different ways, whether it's by
speaking to one another, whether it's by donating their data to larger cohorts of
re search. And we've se en this in speed FasterCures has a group called the TRAIN
network which stands for The Research Acceleration and Innovation Network and it's a
group of venture philanthropy groups. And they come together and do best practice
sharing. You know, we -- on t he list includes groups like the Cystic Fibrosis Foundation
or the Michael J. Fox Foundation for Parkinson's research, the list is long. And these
groups believe that, you know, they're going to keep their eye on the price of trying to fix
their particula r disease so they've been doing a lot of resource and best practice sharing
through some of the vehicles that FasterCures has created.

So, you know, an example of one of the benefits of one of these groups would be the
Cystic Fibrosis Foundation's partners hip over a period of time with a company called
Vertex Pharmaceutical and this resulted in, you know, a game changing drug which is
called kalydeco that really has, you know, propelled forward the science of Cystic

Fibrosis research and, you know, real thi ngs that patients can benefit from. So I think
what you're seeing now with groups like Patients Like Me is that your -- there are
platforms available for patients to share their real world health experiences and data.
So I think what we're going to keep seeing is more and more of this democratization of
data. And there's a number of efforts that involve sort of public private partnerships
between government agencies and not for profits. And it's very exciting because I think
we're witnessing what we're going to see I think more rapid adoption of many these
different things that we've been talking about.

Mark Masselli: We're speaking today with Margaret Anderson, Executive Director of
FasterCures an action tank at the Milken Institute dedicated to removing barriers to
medical progress by speeding up the medical research system. She's also a founding
board member and past president of the Alliance for Stronger FDA. Margaret you've
recently said that in spite of the criticisms often aimed at the FDA and I think we had a
couple of those folks here on a radio show. Your work has focused in on how to make
the FDA function even faster and more efficiently than it currently does. Tell our
listeners more about the scope of the work of the FDA and what ca n be done to
accelerate drug breakthroughs and shorten their research protocols.

Margaret Anderson: So FasterCures as you've said we've made it our policy priority to
both advocate for more appropriated dollars as well as looking at some of the specific
p rograms implemented by the FDA. This is an agency that regulates 25% of every
consumer dollar and it's just a critical component to bringing safe and effective medical
solutions to patients. You know, the FDA has mounting pressures overtime resulting
fro m globalization but they don’t have the resources to really go, you know, tracking
around and do everything that they would need and want. They also have increasing
statutory requirements that are put on them. You know, every time congress asks them
to d o something new, they're given an extra responsibility but not always the same
money to go along with it. In order to make our, you know, drugs come through the
process as quickly as possible, industry works with the agency to help fund some of that
work. In the last user fee process there were something called the patient focus drug
development imitative that was created, it's extremely important to this idea of how do
you engage patients more. So they were asked to do 20 disease specific meetings, so
t hat's the beginning and we've been working with the agency and with congress to really
try to look at how can we advance that science of patient input. And I will point out that
in addition to the development of drugs and therapeutics on the device side t here's been
a lot of activity where they've really been working on this idea of the qualities of patient
preferences and how do you bring that into review decisions. And yeah the FDA's
made incredible strides forward. It's a tough agency because they are , you know,
asked to be fast and efficient but they're dealing with complex, you know, applications.
And, you know, sometimes I think it put between a rock and a hard place where, you

know, the headlines draw attention to something that may have been miss ed and they,
you know, might get conservative after that saying well gee we don’t want to have that
happen again. So it's a very difficult agency to I think have to navigate through. And
Dr. Peggy Hamburg just stepped down as the FDA Commissioner and rea lly did an
outstanding job helping to lead them forward. So I always like to say if you ever get a
chance to meet somebody who works at the FDA say thanks to them because they
have a tough job.

Margaret Flinter: We couldn’t agree with you more, but I won der for our listeners if I
could ask you to really try and focus on as you did in a recent piece in the Huffington
Post it outline some of the top medical research trends of 2015 that are poise to shift the
old paradigm, maybe for our listeners just go thr ough those top ones again. The more
promising trends and how they bring about the FasterCures that we're all seeking?

Margaret Anderson: Absolutely so, you know, we did this every year to understand
what's been going on, what -- you know, what's the chat ter out there and it's very
gratifying because we have the opportunity at FasterCures to work with the entire
biomedical research ecosystem, and listen to a lot of the bright innovative thinkers. We
tend to be pretty spot on about what's hot and what do w e need to be, you know,
thoughtful about. And I would say that, you know, the theme going forward has been
collaboration which we've talked about a bit today. There is also been this theme of a
bipartisan quest for cures, so there's 20% free cures initia tive that I reference is a
remarkable opportunity, it's been led by chairman Fred Upton but really in partnership
with congress women Diana DeGette. And both of them have, you know, deep
expertise in understanding complex issues related to biomedical rese arch and I think
that if they can be successful and pushing this forward it has to go into the senath and,
you know, ultimately be signed at the law. But if they can be successful I really think it
shows the American public that Washington can get somethi ng done that Capitol Hill,
you know, it's serious about advancing things important to the nation. Is it going to be
easy? No, and it, you know, they've released at first a 400 page draft and then it went to
a 200 page draft and now it's back to 300 pages, it's a lot. But as we've been speaking
throughout the show these issues are not easy, if they were easy they would have been
fixed already.

Margaret Flinter: Exactly our philosophy.

Margaret Anderson: Right so, you know, there's also another theme as t his increased
practice of venture philanthropy, I think that everyone will see more and more evidence
that these groups are the little engines that could, they are fund raising their bottom line
every year. They're, you know, through all of those means th e walkathons but they are
targeting that capital very specifically. And they can take risks with that money that's a

little bit different than, you know, some of the sort of, you know, bread and butter we got
to fund these particular science project.

Mark Masselli: Sure.

Margaret Anderson: So I think that's another area. I want to talk about that increased
focus on patient engagement and the science of patient input. I think what started out
as I mentioned about the HIV/AIDS activist, it started out in terms of advocacy but it's a
scientific discipline now. And it's really looking at how can you accommodate patient
needs and preferences and put them into a process of developing, regulating and
delivering therapies. And I think there's a, you know, a g rowing community of people
who are focused on it, trying to figure it out and we have a specific program that's been
looking at benefiting risk as well as value and coverage which I think is another really
hot area that we're all seeing headlines about thi s. You know, looking at the cost of,
you know, our therapeutics. So as we've talked about getting a drug approved by
regulators it used to in some ways be the finish line, you know, if you got FDA approval
yay okay that means patients can have access. T hat's not such a certain proposition
anymore, you now have to demonstrate the value to patients. And so FasterCures is
working with a lot of those disease foundations because they have concrete data about
their patient populations. So they're able to say the introduction of this particular
product completely change the paradigm of how these people are living their lives,
they're going back to work, they're, you know, productive members of society now
without symptoms. So they can show the value propositi on. Patient groups will be
playing an increasingly critical role and closing the gap between the evidence that
regulators need to just approve a product. And then the evidence and information that
payers are going to need to make their decisions.

Mark Ma sselli: We've been speaking today with Margaret Anderson, Executive Director
of FasterCures an action tank based at the Milken Institute which is dedicated to
removing barriers to medical breakthroughs by accelerating the pace of research. You
can learn more about her work by going to FasterCures.org or you can foll ow her on
Twitter at @MargaretAinDC. Margaret thank you so much for joining us on
Conversations today.

Margaret Anderson: Thank you so much, I appreciate it.

(Music)

Mark Masselli: At Conversations on Healthcare we want our audience to be truly in the
know when it comes to the facts about healthcare reform and policy. Lori Robertson is
an award winning journalist and managing editor of FactCheck.org a nonpartisan, non -
profit consumer a dvocate for voters that aim to reduce the level of deception in US
politics. Lori what have you got for us this week?

Lori Robertson : Well we recently looked into whether marijuana is a gateway drug as
New Jersey Governor Chris Christie claimed and sayin g that he would crack down on
marijuana sells and use in states that legalized marijuana for recreational use. It turns
out the science on this topic is far from settled, there are correlations between
marijuana use and other drug. But there is no conclu sive evidence of causation that
using marijuana causes the use of other drugs.

Studies have found that those who smoke marijuana are more likely than those who
don’t to use other drug. The correlation is there, but there's not evidence of causation
that s moking marijuana causes one to use other drug. In 1999 report from the Institute
of Medicine said exactly that, marijuana use 'Typically precedes rather than follows the
use of other drugs.' But the Institute of Medicine said it doesn’t appear to be the c ause
of serious drug abuse or even the most significant factor in predicting drug abuse.

We spoke with spoke with an expert at the national institute on drug abuse which is part
of the national institutes of health who told us the scientific community was still debating
this complicated issue which has been contentious over the years. For more on the
studies that have been conducted on this topic see our website at FactCheck.org. I'm
Lori Robertson.

Margaret Flinter: FactCheck.org is committed to factual accuracy from the country's
major political players. And is a project of the Annenberg Public Policy Center at the
University of Pennsylvania. If you have a fact that you'd like checked email us at
chcradio.com we'll have FactCheck.org's Lori Robertson check it out for you here on
Conversations on Healthcare.

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Margaret Flinter: Each week, Conversations highlights a bright idea about how to make
wellness a part of our communities and to everyday lives. Disease from unclean water
cause more deaths in parts of the world than all forms of violence including war. And of
the 30.000 people who die every week from unsafe water and lack of sanitation 90%
are children. At any given time up to 30% of the tens of thousands of wells across the
African Conti nent can be out of commission. And sometimes they never get repaired.

Robert Lee: Yeah sometimes they have trouble like collecting funding and managing
that well in order to pay for the (inaudible 22:34 ) and the labor to install it. And a lot of
times t here's no valid stable infrastructure in place that they could reach out to if they
need (inaudible 22:42 )

Margaret Flinter: Robert Lee is the Director of Special Programs at Charity Water an
innovative non - profit, privately funded in a way that every dol lar donated goes directly to
building and maintaining wells. He says they decided to rig all the wells with GPS

markers and special sensors that send a message to a command center when a well is
starting to malfunction.

Robert Lee: So this is usually a c ommunity hand pump well, so we have -- make a
(inaudible 23:06 ) that will last a really long time. So the battery don’t need to be
replaced, and then I have (inaudible 23:12 ) to be able to detach from the data what's
really going on. The hope is that thi s is the actual support system that they would need.
We're putting a phone numbers for them to call on the water plant we're giving them
training, motorcycle tool and yeah enabling them with a combination of infrastructure as
well as technology through th e sensors that a building be electronic tablet survey
systems as well as (inaudible 23:38 ) so that they could be able to manage their staff as
well as other repairs that come in.

Margaret Flinter: Often within days a trained well repair person is dispatch ed to the
broken well. Which in many cases is the well that provides the only clean water for an
entire community. And in Africa alone people mostly women and girls spend an
estimated 40 billion hours a year collecting and transporting water to their vil lages.

Robert Lee: And the stakes of it are like women aren't able to take care of their
(inaudible 24:07 ) children are able to go school.

Margaret Flinter: Charity Water's alert system puts the pumps back in action supplying
not only clean water for dri nking and sanitation but for small local farms as well which
feed entire villages and provide a source of income for the farmers. Charity Water,
building thousands of wells across Sub - Saharan Africa deploying a digital alert system
to warn of a well's mal function and sending help to repair it. Ensuring that clean water
continues to flow into a community, now that's a bright idea.

(Music)

Margaret Flinter: This is Conversations on Healthcare, I'm Margaret Flinter.

Mark Masselli: And I'm Mark Masselli, peace and health.

Female: Female: Conversations on Healthcare broadcast from the campus of WESU
at Wesleyan University. Streaming live at WESUFM.org and brought to you by the
community health center.