Sr. Director at Pew Charitable Trusts, Allan Coukell, Discusses Opportunities for FDA Reform

Allan Coukell – Pew Charitable Trusts

Mark Masselli: This is Conversation on Healthcare, I am Mark Masselli.

Margaret Flinter: And I am Margaret Flinter.

Mark Masselli: Well, Margaret the tune has started to change, coming from the
congressional leadership and the president about the ques t to rapidly re - appeal
the Affordable Care Act and the operative word now seems to be repair.

Margaret Flinter: And it’s been very interesting to see some of the health
industries medical societies weighing in as Republicans work to now replace the
legis lation, they are hearing from the number of health industry groups are
asking, no leave certain aspects of the law intact.

Mark Masselli: The American Congress of Obstetrician and Gynecologist
ardently opposed to the ACA in 2010. Now they are urging Con gress to keep
intact certain measures of the law such as the rule that women can’t be charged
higher premiums due to their gender, they know the law has had some positive
impact on women’s health.

Margaret Flinter: Top representatives from a number of th ese organizations
have been meeting with the GOP leadership to ensure that certain aspects of the
law do remain intact. And I think we will hear more language like this in the
coming months as this new reality sinks in for the leadership in Congress as we ll
as for the President. I guess we can say, market forces do come to bare on
these issues.

Mark Masselli: Absolutely and the President has started to sound a similar tune
as well, he may not have a replacement sorted out until earlier 2018, with the
ph armaceutical industry looking at some significant changes we decided to invite
an expert on matters of drug safety and how the FDA works.

Margaret Flinter: Allan Coukell is the Senior Director for Health Programs at the
Pew Charitable Trust where he over sees a variety of health topics including FDA,
drug and medical device safety, the pharmaceutical supply chain. He is bringing
us a depth of understanding on how the FDA works and how it might be
recalibrated to accelerate the drug approval process, so we look forward to that
conversation.

Mark Masselli: Lori Robertson, also checks in, the Managing Editor of
FactCheck.org is always looking to shine a light on misstatements spoken about
health policy in the public domain. But no matter what the topic, yo u can hear all
of our shows by going to www.chcradio.com .

Margaret Flinter: And as always if you have comments, please email us at
[email protected] or find us on Fa cebook or Twitter because we would

Allan Coukell – Pew Charitable Trusts

love to hear from you. Now we will get to our interview with Allan Coukell in just
a moment.

Mark Masselli: But first, here is our producer Marianne O’Hare with this week’s
Headline News.

Marianne O’Hare: I am Marian ne O’Hare with these Healthcare Headlines. Tom
Price has been approved to secretary of health and human services, the party -
line vote, going through in a late night session in the Senate. The conservative
orthopedic surgeon from Georgia, has long been ma king a case for the appeal of
the Affordable Care Act, even though President Trump has recently said, he may
not have a replacement plan in place until early next year. Senator Lamar
Alexander, Chairman of the HELP Committee which governs health policy is
urging more support in Congress for the repair approach which he says, will be
far less disruptive to the healthcare market place.

Meanwhile at a recent meeting of the Conservative Heritage Foundation, a cadre
of Republicans vowed to move ahead with thei r plans for a swift repeal, planning
to eliminate certain taxes that help pay for the law, by passing budget
reconciliation measures that don’t require a 60 - vote majority in the Senate. Still
there is a high degree of confusion and concern within the heal thcare industry as
CEOs and budget planners catch their eyes towards an uncertain future under
President Trump and an HHS secretary who are so vocally committed to
repealing the healthcare law.

The numbers are in, in spite of tremendous downward political pressure from the
incoming presidential administration. 12.2 million Americans manage to sign - up
for health coverage on the insurance marketplace exchanges. This in spite of
spike in premiums for some markets around the country this year and fewer
insur ers to choose from. Still those spikes are offset by commensurate tax
subsidies under the Affordable Care Act.

An estimated 91 Americans per day are dying from opioid overdoses while the
nation’s Public Health officials try to get a hand on this deadly c risis, the
company that makes the version of the overdose antidote naloxone, is being
accused of price gouging, price for the drug was hiked 550% in recent months.
Missouri Senator Claire McCaskill demanding answers from Kaleo
Pharmaceuticals which makes and markets the drug. I am Marianne O’Hare with
these Healthcare Headlines.

Mark Masselli: We are speaking today with Allan Coukell, Senior Director for
Health Programs at the Pew Charitable Trusts where he oversees a variety of
health topics including the FDA drug and medical device safety, the
pharmaceutical supply chain, prescription drug dependency, opioid overdose,
food safety and school nutrition. Prior to joining Pew, Mr. Coukell was a clinical
pharmacist in oncology at the London Health Science Center in the Ontario

Allan Coukell – Pew Charitable Trusts

Regional Cancer Center. He is a Vice Chair of the Medical Device Innovation
Consortium and a board member of the Reagan Udall Foundation for the FDA .
He earned his Bachelors of Science in Pharmacy at the University of Manitoba
and d id his residency at the Winnipeg Health Sciences Centre. Allan, welcome
to Conversations on Healthcare.

Allan Coukell: Good to be with you.

Mark Masselli: Yeah, at Pew you cover sort of this really wide swath within the
pharmaceutical industry, which is covered largely by the food and drug
administration. And we have a new administration in - charge now, President
Trump has talk tough about changes he wants to see at the FDA. I wonder if you
could help our listeners understand the scope of work done at the FDA and how
making sweeping changes are not quite so simple.

Allan Coukell: Yeah, I think a lot of people when they think of the FDA, they think
of approving new drugs, but they also have oversight over for lot of the food
supply, medical devices, t obacco, things that we never even think of, microwave
ovens. There are 300,000 over - the - counter drug products that FDA oversees
and 55,000 dietary supplements. And I have heard new commissioners after
they come in say, you sort of come into the job with a vision of what you want to
do and on day one, you get hit with a food and safety outbreak and it’s like
drinking from the fire hose. And so there is a lot going on at the agency, a lot of
staff and things change slowly there.

Margaret Flinter: You kno w and I am reminded of our interview a while back with
Dr. Margaret Hamburg who served as FDA Secretary under President Obama.
And she really gave us an insight into just the shear enormity of the scope of
work conducted by the FDA. And certainly you kno w we have seen lots of
criticism for what some view as the slow pace of progress for the drug testing
protocols, but she gave us an insight into the deficit of personnel, research
personnel. Where are we now with this shortage of person power at the FDA,
how has it hampered productivity and what do you see happening with that as we
move forward.

Allan Coukell: That would mean that real challenge just within the center that
reviews new drug applications there are about 700 unfilled positions out of a tota l
of about 5000. So that’s a pretty big staffing deficit and that makes it hard for the
agency. They do pretty well reviewing new drug applications and generic drug
applications, the thing that often get short shrift though is all of the other things
tha t would really help the industry and consumers and patients which is the
ability to have scientists thinking about what should the guidelines be, how
should we approach clinical trial design. And so having a lot of unfilled positions
is a real challenge.

Allan Coukell – Pew Charitable Trusts

Mark Masselli: You know I know you have been concerned about the rapid
expediting of the approval process at the FDA. Just wondering if you look at the
opioid crisis and you know the role that the manufacturers of the drugs play that
really enticing peo ple, I think to overprescribing, any reflections on how we might
prevent that type of problem again?

Allan Coukell: You know it is, you called it a crisis and that’s exactly right more
than 33,000 Americans died from an opioid overdose last year and of c ourse
that’s only the tip of the iceberg for every person who died, there is somebody
who is struggling with substance - use disorder and so it’s really big. You
mentioned in your introduction that I was an oncology pharmacist at one stage of
my career and so I certainly recognize that these drugs are an essential part of
the armamentarium for managing pain. And people who have pain has to get
effective pain control at, but it’s certainly true that this increase in opioid misuse
has tracked very closely the increase in prescribing, in the country. And I think
the problem there is we collectively use the drugs sometimes in places where we
would be better off using non - pharmacological management and so on.

Margaret Flinter: You know the reality of this opio id crisis has been devastating.
Communities are trying to grapple with it, clinicians are trying to grapple with it.
You recently wrote an analysis at Pew on what some of the best ways might be
to confront the addictions dilemma and you said that the med ication assisted
treatment approach has so far yielded the best results. Maybe share with our
listeners the national policies that were hearing and have seen some progress
on, what should people know has been going on?

Allan Coukell: Yeah it’s an epidem ic that really requires a multipronged response
and changes in prescribing. But once people have developed a dependence on
the drug, we have to be able to get them into effective treatment. And we are not
doing so well, only about one in 10 people are re ceiving any kind of treatments.
And then within publicly funded treatment programs only a tiny fraction of those,
include FDA approved medications to manage the disease. And that is
something that the evidence has shown is, by far in a way that most effe ctive
strategy. Once the brain has undergone a chemical change where its dependent
on these molecules, it’s usually not just a question of personal determination to
get off the drugs, it really helps it in combination with cognitive support and peer
suppo rt, you have a drug that helps reduce the cravings or replace the need for
that opioid or elicit heroin or what have you.

And so increasing access to MAT, Medication - Assisted Therapy is crucial, but we
also need treatment systems that are ready when someb ody decides they are
ready for treatment. If you have somebody who has a substance - use disorder
and they say, you know I want to get off these drugs, we can’t afford to wait three
weeks while they get into a treatment program. And so there are states and
jurisdictions that have been getting much better and making treatment available
the sort of no wrong door idea where whether somebody hasn’t encountered with

Allan Coukell – Pew Charitable Trusts

the criminal justice system, when they walk into Federally Qualified Health
Center and say, I wou ld like to have some help to get off the drugs, we have to
have systems that take people, manage them acutely and then transition them to
long - term management. So some of that is how we organize the care delivery
and some of that is how we pay for it and the expansion of Medicaid has been
beneficial in getting more people into treatment, Congress in the last year has
increased federal funding to states to support treatment programs so those are
all good things. But as Congress grapples with the future of health coverage,
there are real risks, we can take some comfort I think in the fact that there is
bipartisan recognition of how crucial it is to address this crisis.

Mark Masselli: We are speaking today with Allan Coukell, Senior Director for
Health Prog rams at the Pew Charitable Trusts where he oversees a variety of
health topics including the FDA, the pharmaceutical supply chain, opioid
overdose, food safety and school nutrition. You know the President has been
very busy meeting with lots of people inc luding representatives from some of the
largest pharmaceutical entities. And he has promised to take action on reducing
regulations in taxes, but they have to do more to bring prices down. And on the
other hand he did receive a degree of praise from the rare disease community for
promising to advance the Right to Try bill, which would make experimental drugs
more readily available to those with terminal illness. You just raised the issue of
bipartisan support, I assume that all this is going to take a wi lling Congress to
make all of this happen.

Allan Coukell: So if we talk about the challenge of drug spending which is very
much front and center, it’s a real challenge. The big challenge on the drugs
spending front is that right now, 1% of prescriptions that account for 30% of our
national spending. And those tend to be the new high cost specialty
medications. It’s sort of good news, bad news, we are in really exciting era,
scientifically for therapeutic advances, but as more and more of us get access to
and need those innovations, that kind of price growth looks unsustainable. And I
think we have to make sure that where we can inject competition in the market
we do, both with generic drugs and the generic equivalent of biological drugs.

We also have to make sure that we somehow correlate rising prices with clinical
value and not overpay something that we haven't historically been very focused
on in healthcare in general in the U.S. So there is a lot of policy interests as you
mention both from the Pr esident and from the Congress. In terms of the speed
of approval, FDA makes it determinations much faster than it used to. And I think
it’s important to recognize that in the overall timeline of drug development, the
months that the application sits at t he FDA is a pretty small part of the overall
cost. So the big costs are actually discovering the drug, developing the
molecule, writing the clinical trials, that’s where the sort of long - term savings are
in terms of being able to reduce drug development c ost.

Allan Coukell – Pew Charitable Trusts

Mark Masselli: I don’t think people realize that it’s like nine months at the FDA on
average or maybe it’s a little less from bench to bedside that’s really not where all
the time is taking, is that right?

Allan Coukell: Yeah I mean it depends on the product you are talking about and
FDA, now has a mechanism for taking the drugs that are kind of newest and
most novel and the ones they consider breakthroughs and putting them at the
front of the queue and moving them through the process really fast, but yeah
people often say, it takes a dozen years to develop a drug, the first 11 years say,
are doing the science that leads to eventually being able to submit an application
to FDA.

Margaret Flinter: You know and I think, we were caught somewhat off - gu ard
when all of a sudden there was a stir within the scientific and public health
communities that the Trump administration was appointing, known opponents of
vaccinations to some key positions. I think we are surprised to find ourselves
maybe having to f ight this battle again. What’s your read on that and how do we
keep the current administration and congressional leaders focused on the need
to really rely on evidence - based science as we look at these potential new
policies and legislations that affect t he population health so much.

Allan Coukell: We are certainly tracking it very closely and as you say vaccines
have been one of the great public health successes of the past century. And the
concerns about side - effects of vaccines have been very extensi vely studied by
scientist at the CDC and Academia. And so it really is crucial that as we move
forward, we not take a stance but frankly put the children at risk, because as we
know there are a lot of vaccines that only work if you have a certain level of
immunization in the population. And so if my neighbor doesn’t vaccinate, my
child may be at risk.

st
Mark Masselli: You know certainly the 21 Century Cures Act which had
bipartisan support, was advancing some of the activity that’s going on and the
act, year marks money for the Cancer Moonshot as well as the Precision
Medicine Initiative. And as you look out over the future of biomedical research,
drug and device deployment, what types of transformations are going to be
st
required to confront some of the more significant 21 century problems that we
are going to face in the areas of food and drug safety.

Allan Coukell: Yeah, as you say it’s an amazing time and last year a number of
new drugs came to market that cure Hepatitis C, there was a lot of focus on the
cost of those drugs, but lost a little bit was just the excitement of a cure. You
know and as we look forward, you know hopefully there will be a lots more of
those but you can sort of think in a concrete way, well what if we had a drug that
we th ought might prevent Alzheimer’s disease, but people had to take it you
know for 20 years before they started to develop symptoms. What would a
clinical trial for that look like? What would be the ethics of enrolling healthy

Allan Coukell – Pew Charitable Trusts

people into a clinical trial o f a drug with unknown affects? And so we need a lot
more thinking about clinical trial design and what are the you know validating the
kind of biological markers that are good predictors of how people will eventually
do in terms of real [inaudible 18:16] what are the different kinds of evidence. So
beginning to shift from I think and old model of thinking of drug approval is really
binary, to beginning to see it as a long - term process of continuing to refine and
evaluate evidence.

I don’t think anything will ever replace the randomized clinical trial as the gold
standard of figuring out in a scientific way, what something works, but we also
have to get so much better at learning from real - world experience, when some
things is on the market and being able to pull data from health records and
insurance claims and maybe eventually even people’s own wearable devices or
personal reports and continue to learn and refine our understanding. And along
with that shift, has to come a shift in communicating about evi dence, so that we
move into a market place of ideas where there is sort of an ongoing refinement of
what we know and collectively understand about products. And also frankly how
much we are willing to pay for them.

Margaret Flinter: We have been speakin g today with Allan Coukell, Senior
Director for Health Programs at the Pew Charitable Trusts where he oversees a
variety of health topics including the FDA, drug and medical device safety, the
pharmaceutical supply chain, prescription drug dependency and t he opioid crisis.
You can learn more about his work by going to www.pewtrust.org or follow him
on Twitter by going to @coukell, C - O - U - K - E - L - L. Allan thank you so much for
joining us on Conversations on Healthcare t oday.

Allan Coukell: Had a great pleasure to be with you.

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 journ alist and Managing Editor of FactCheck.org,
a non - partisan, nonprofit consumer advocate for voters that aim to reduce the
level of deception in U.S. politics. Lori, what have you got for us this week?

Lori Robertson: Well, Senator Bernie Sanders and Sen ator Ted Cruz appeared
in a CNN debate to discuss the future of the U.S. healthcare System. And both
man repeated claims we have checked before. Sanders said that the United
States spend “twice as much per capita on healthcare as do the people of any
oth er country”. Sanders has a point that United States spends a lot more per
capita than other countries on healthcare but twice as much, no that’s not
correct. The U.S. spends twice as much as the average spent by other
developed nations. According to 201 5 figures from the Organization for
Economic Cooperation and Development the U.S. healthcare spending was
$9,451 in 2015 per person. The average for 35 countries was $3,814 but the

Allan Coukell – Pew Charitable Trusts

second place country Luxemburg spent $7,765 or 18% less per capita than th e
U.S.

Senator Cruz meanwhile said that the Affordable Care Act had “driven up the
cost of healthcare.” He said the average families premiums have gone up
$5,000. That’s a misleading take on premium growth. For one that’s the rise in
the average premiu m for an employer sponsored plan for a family including both
the premium paid by the employee and the portion paid by the employer. The
total average cost for a family plan rose $5,462 between 2008 and 2016. The
average employee paid portion rose $1,923 also that increase an employer
sponsored premium is lower than the premium increase for the previous 8 year
period, both in raw dollars and in the rate of growth. The total average family
plan cost increased by 97% from 2000 to 2008, but it went up by 43% from 2008
to 2016. And that’s my FactCheck for this week; I am Lori Robertson, Managing
Editor of FactCheck.org.

Margaret Flinter: FactChecks.org is committed to factual accuracy from the
country’s major political players and is a project of the Annenb erg Public Policy
Center at the University of Pennsylvania. If you have a fact that you would like
checked, email us at www.chcradio.com we will have FactCheck.org Lori
Robertson, check it out for you, here on Conve rsations on Healthcare.

Margaret Flinter: Each week conversations highlights a bright idea about how to
make wellness a part of our communities and to everyday lives. Diabetes is a
chronic illness for which behavioral choices such as diet and exercise a re
extremely important. But incentivizing behavior change and large patient
populations is very challenging. A recent study done by Emory University and a
nonprofit organization focused on improving the health of India’s population of a
billion people, f ound the text messages sent through smartphones, might be a
powerful tool in promoting diabetes prevention behaviors. They partnered with
India’s leading provider of mobile phones Nokia to harness a research cohort of
the million clients to receive diabet es prevention text messages.

Nalini Saligram: So the text messages themselves were developed with Emory
University, Rollin School of Public Health and then we adapted them with lots of
consumer feedback.

Margaret Flinter: Nalini Saligram CEO of the Aro gya Foundation, the text
messaging study was designed to generate improved activity around four simple
goals, consume more fruits and vegetables, avoid fried foods and exercise
regularly.

Nalini Saligram: The sequence of the messages and how frequently t hey were
texted was all based on behavior change theory as well as on Nokia’s
experience. So we ended up sending it twice a week for six months.

Allan Coukell – Pew Charitable Trusts

Margaret Flinter: Participants who received just two text messages per week,
remind me then to keep their di et and exercise goals, showed an average 40%
more compliance with those activities than those who did not receive the
messages. Dr. Saligram says, it could prove a useful tool for clinicians trying to
affect behavior change across large patient population s. A low cost targeted text
messaging system sent directly to consumers, reminding them of the power they
have to maintain simple lifestyle changes that can improve their chances of
preventing or better managing diabetes and other chronic illnesses, now t hat’s a
bright idea.

Margaret Flinter: This is Conversations on Healthcare, I am Margaret Flinter.

Mark Masselli: And I am Mark Masselli, peace and health.

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.