-: Good afternoon everyone.
Welcome to Ethics Grand Rounds.
Before I introduce our speaker,
let me remind everyone that we, next month's presentation
is from Jim Dubois who is the, who's a psychologist
and ethicist and director of the ethics program
at Washington University in St. Louis.
And he has done a very interesting study,
NIH funded study of several hundred physicians,
it's a qualitative and quantitative study
of several hundred physicians
who got into situations of serious ethical misconduct.
Things like inappropriate prescribing,
sexual relations with patients and so forth.
And so he's going to both present his findings
and also some advice about how we can better serve
those who are patients as well as those who offend.
So please stay tuned for that.
It's a special privilege to introduce Professor Steve Inrig,
who has the paradoxical relationship to this institution
being a colleague as well as a former colleague
in that he spent, oh what, six years or so
here at UT Southwestern in the then
Department of Clinical Sciences
and now the Department of Population and Data Sciences,
where he continues to be an active collaborator
particularly for that department's efforts
in health surveillance, disparities, and prevention.
And so in that way he's both a former colleague
and a current colleague.
His official position currently is as the associate,
and can I announce your promotion?
(laughing)
No, okay, I can't announce it yet.
But he is currently associate professor
in health policy and management
at Mount Saint Mary's University in Los Angeles.
He's director of their graduate program
and masters of science in health policy and management,
director of interdisciplinary health care research
at that institution.
And he's in the Department of History and Political Science,
Health Policy and Management, again at that institution.
He has an extensive education,
a BA from UNT in American history,
an MA in intellectual history
from Trinity International in Illinois.
He got his PhD in history of medicine
and health policy at Duke.
He has a postdoctoral position completed
at the University of North Carolina, Chapel Hill
where he completed his first book about AIDS care
in North Carolina.
And then he came to us in 2014 at UT Southwestern,
or left UT Southwestern to take his current position
at Mount Saint Mary's.
But while at UT Southwestern,
in addition to functioning, he was one of the first I think,
recipients of the masters degree in clinical sciences
that we now have offered for many years.
He's got dozens of publications,
I just wanna mention a couple of his most,
his two most recent books.
One was the aforementioned,
"North Carolina and the Problem of AIDS:
"Advocacy, Politics, and Race in the South"
Published by the UNC Press.
And then more recently in 2017 his
"History of the AIDS Pandemic:
"Mobilizing the Global Response, Mobile Health Governments
"in the WHO", that was in collaboration with Michael Merson
who was a primary leader in those efforts.
So without further ado,
please welcome my colleague and friend Steve Inrig.
(audience applauding)
-: Well thank you very much for having me
and I will do my best to not to fill up the whole time
so we can talk, but it's great to be back
and see a lot of very familiar faces and dear friends.
So thank you for the opportunity to be here.
I've written a lot, studied a lot on HIV among other things
and what I wanna talk a little bit about today
and I'll slam through all my slides on this,
but when I was, the first book I wrote
was talking in part about the epidemic in North Carolina.
And North Carolina happens to be the place
where the first drug that worked against HIV
was developed and then brought to market.
And the second book was about global governance,
and one of the challenges was is the company
that brought this drug to market, then refused
to allow flexibility in patents so that the epidemic
in Africa went, oftentimes without access
or full access to drugs, both the first drug
and a number of other drugs until the early 2000s
when things changed.
And so in terms of ethics, I just wanna think
about something called the Health and Human Rights Framework
which has really helped to push drug companies
into getting involved and thinking about flexible ways
to use their patents to give access
as well as the governance structure
that's opening up some of the restrictions
that have been placed in there.
So lemme just move forward.
Obviously some of this stuff is gonna be really familiar
for all of you, so I won't have to spend
a lot of time on there.
I'm not here to bad-mouth research,
obviously it's been really tremendous in lots of ways.
Biomedical research, we've developed lots of new vaccines,
we're doing some fantastic things in cancer and HIV,
and it is strengthened prevention and whatever,
so it's very very important.
And we're seeing all sorts of different diseases
where burden of disease has fallen.
So the international drug regime research and development
is very very important.
And we're seeing globally the burden of disease
has actually dropped.
If you take a look at that slide you'll notice
there's kind of a little bolus there in the middle,
or maybe a big bolus in the middle,
and that's Sub-Saharan Africa
where HIV claimed a lot of folks.
And you can imagine what that would look like
if that had been addressed differently.
But in many respects, trends are moving
in a very positive direction.
That being said, there's still a lot of challenges.
And this is the thing that certainly interests me.
About two billion people globally
still have inadequate access to needed medicines.
World Health Organization
will call them essential medicines,
but generally speaking a list of medicines
that countries need to have to be able to provide
robust and comprehensive health to their populations.
We have brought new medicines
and essential medicines to market,
37 over the past couple of decades,
but that only accounts for 4% of new drugs
that are coming to market,
whereas neglected tropical diseases
constitute about 11% of the disease burden globally.
And obviously not everything needs to be equal,
but it's one of the things where it affects
a huge portion of the population,
but it's underrepresented in the types of research
and the types of drugs that are being brought to market.
Some of that is just the nature of science.
Some of these diseases are very, very difficult.
It can't be a one to one correlation.
But the reality is in fact
that we have responded to a lot of these emergencies,
particularly Ebola
and other African viral hemorrhagic fevers,
which causes great concern.
And in the meantime, from 2009
research in drug development and some of these other areas
has actually declined.
And so, there is an important need for us to continue
work in this area.
One of the challenges is is that globally,
the global research and development market
is focused on kind of a market-based model.
And for HIV, that's been very, very important.
But in other diseases,
Zika, Ebola, Neglected Tropical Diseases,
there are all sorts of people
who do not have the power of the purse
to be able to encourage drug companies
to invest in diseases that they have.
And so, countries, organizations
have started to look to other mechanisms
to try and spur drug companies,
try to spur research organizations
into moving into these areas
and developing drugs that might not be,
cost benefit analysis makes sense,
but might have other value systems in play.
And one of the value systems that people have looked to
in spurring activism in these areas
is something called the Health and Human Rights Framework.
And so, I wanna talk a little bit about that.
It comes out of the World Health Organization.
World Health Organization,
I don't need to go in too much detail,
but it's the main body coming out of the United Nations
after World War Two
that was focused on addressing the needs
of vulnerable populations around the world,
and making sure to deliver healthcare.
Since 1949, it has largely been the entity that's focused on
the tropical diseases that have been neglected
by a lot of Western countries,
and that's kind of been its primary focus.
So this has been a main driver.
I don't need to go into all the details other than to say
that in 1948, there were about 56 members.
Right now, there are 192 different countries
that are participants in this.
Some countries belong to the World Health Organization
that don't belong to the United Nations.
And so, they have their own World Health Assembly
where they go and share data, talk about health needs,
and then try and come up with strategies
and programs that impact them.
One of the things
that the World Health Organization has done
is to really capitalize on the larger concept
that the United Nations was built on,
which is not just protecting people
but preserving their rights.
So avoiding war, but also thinking about human rights
and instantiating them in everyday life.
For the World Health Organization,
this means that they consider health to be a human right.
And they mean this in a very particular way,
some of which seems rather audacious
in the way they've worded it.
First of all, they envision
the highest attainable standard of health
is a fundamental right for everyone.
And how they define health is
a state of complete physical, mental, or social wellbeing,
not merely the absence of disease or infirmity.
Which if you're a parent,
there is no way you're ever gonna get to that
just by the nature of the anxiety your kids cause you.
So, but you understand that that's very aspirational.
But the point is not merely that people aren't sick
but they're living in robust health.
But then what the World Health Organization
and the United Nations in general says
is that states have an obligation
to create an environment for their people
to move to that right of health.
Now, they recognize that that can't happen
just by snapping your fingers, that it's a process.
And our dearly beloved coach
liked to talk about working the process.
And the WHO has a process in thinking through what it means
in terms of moving towards the right to health.
First of all, they recognize it's progressive realization,
that countries have to have
a strategy that they're moving towards.
So even if they have not moved to comprehensive health
for all their citizens,
that they're at least trying to do that.
But that they are using the maximum amount of resources
including international assistance
to move in that direction.
Obviously, for low income countries
there's a lot more international assistance
that they're relying on.
And there's huge debates as to what portion of one's budget
one ought to set aside for health.
World Health Organization has given targets,
and those targets are looked at and smiled at
and then people talk about reality,
'cause it depends on what your circumstances are.
If you're in the middle of a civil war,
as to how much of your budget you're gonna designate
to your health system.
But the World Health Organization says
that there are a core set of minimum obligations
that all countries
that belong to the World Health Organization
need to uphold.
One is that they should be
nondiscriminatory in their health systems.
Which means that racial groups, ethnic groups,
religious groups should not be getting
second-tier level of care,
that everyone should be having access to care.
As well as essential levels of food,
essential levels of housing and shelter, sanitation.
And then they talk about the provision of essential drugs.
Again, this is not a whole panoply of the pharmacy
that's available to people,
but the major diseases that people are dealing with,
both communicable and non-communicable,
that the country would have those available to people
to be able to access.
And then finally,
equitable distribution of health facilities
and that kind of thing.
For my talk today, I'm gonna focus on the provision
of essential drugs.
I mentioned that the United Nations
views rights and obligations as state-focused.
The idea is, is that a state has limited sovereignty.
It's granted sovereignty by its people.
And other member states acknowledge the legitimacy
of that sovereignty to the extent
that the state actor provides rights and services
to its citizens.
So the obligation is to respect the rights of its citizens,
which means that they don't interfere
with its citizens from enjoying the rights.
That they protect their citizens
if there are other people who are gonna try
and take those rights away.
And that they themselves work to fulfill those
so that individuals can have
a full realization of their rights.
But what if you're a country
and you can't afford drugs?
If you have a requirement to provide essential drugs
to your people
but a multinational corporation
owns the patents to those drugs and sets the price
and it's not something you as a low income country can pay,
what do you do?
Are you, as a country,
violating the rights of your citizens,
or are there some other mechanisms that you can use
to fulfill those obligations?
Or do you just let them fall by the wayside?
Who's gonna enforce it?
Who's gonna come and say,
you're not doing a good enough job feeding your people?
So this is the problem of essential medicines
and some of these other things.
Essential medicines satisfy the priority healthcare needs
of a population.
The World Health Organization has a list
which they update every couple of years.
It changes over time.
Obviously, new diseases come,
other diseases we get new technology and better medicines,
and therefore those come into play.
And different countries have different, you know,
disease burdens.
So what is true in Sri Lanka may not be the same
as what's in Belarus.
And so, those different countries
have different requirements by the WHO
to provide those things.
The reality is is that 30% of the globe
does not have access to these essential drugs at all.
And even in countries that are providing
these essential drugs, in the lowest 27,
in low income countries, the 27 lowest,
only about 35% of their populations
have access to enough of these
for them to live disease-free.
And so, the reality is is that essential drugs
are a nice aspirational goal,
but for a variety of reasons
there are all sorts of people around the globe,
as I mentioned, about two billion,
who still are lacking access to those.
So for states to fulfill their rights,
how do they do that
when they don't control access to those things?
Well, this is where the history of HIV comes in.
These have been problems for a long time.
But, whoopsee daisy.
Sorry about that.
But AIDS really served as kind of a catalyst
for people to analyze this system
of research and development globally
and the unequal distribution of drugs
and other healthcare assets and start to say,
we need to rethink some of these things.
So I wanna say at the start,
AIDS did not create the idea of health and human rights.
That's been around for a while.
Obviously the World Health Organization has had that
since the 1940s,
and there's groups like the International Red Cross,
Amnesty International, Doctors Without Borders
and Doctors of the World,
which arose with this idea of protecting human rights
and linking health to human rights.
So this has been around for a while.
But what HIV did was
it forced people to rethink the paradigm
based on how HIV was affecting people.
Some of you in this room are not old enough
to know about the advent of HIV,
so you've lived in a world that always had HIV.
But there are others of us who have gray hair like me,
or color their hair so they don't have gray hair like me
who can remember kind of when it emerged.
And at first it was kinda something curious,
and then it became something terrifying.
In the United States, you can see the rise from 1980
up until about 1995, '96,
when protease inhibitors really changed things.
But it became a dramatic killer
of multiple groups of people across the country.
It wasn't just across the country, but across the globe.
And while we didn't initially realize it,
in fact it had started in Africa many decades beforehand
and had spread throughout the world
long before we started to recognize it.
But Africa was most severely hit.
So in 1988 you can see these countries
starting to get between 10% to 30% of the population.
By 2003, Sub-Saharan Africa, particularly Southern Africa,
had just outrageously high rates of HIV
and the associated death.
So AIDS was obviously a dramatic disease
that needed to be addressed.
Also though, it was a social disease
that brought all sorts of taboos.
It's been treated very, very differently
than we think of things like Ebola
or even tuberculosis, to a certain extent.
There came with it discrimination and shame.
So people could lose their insurance,
gay men particularly had their social establishments closed,
people were denied insurance or they lost jobs,
there was housing discrimination.
To this day, there's still violence towards people
who are HIV positive.
If you are a parent and you had HIV,
oftentimes you could lose your parental rights.
And so, this created a whole number of organizations
that emerged to try and address
not only the devastation of the disease
but also the social implications and lack of social support.
Early on, because of the recognition
that this was more than just a disease
but also a social phenomenon of discrimination,
a number of groups started to think about
the violation of human rights that was going along
with the treatment of people with these diseases.
And so, the Council of Europe,
which is part of the European Economic Community,
or now the EU,
came out in the early 1980s and said that
in terms of disclosing people's AIDS status
that we need to do so
in a context we're protecting their rights.
The World Health Organization up until that time,
even though it had been the one promulgating the idea
of health and human rights,
it didn't really talk about them.
Health was a human right, they said,
but then they didn't use that language.
Starting about 1985 they noticed that people,
particularly from Africa,
were being denied entry and migration
into other countries.
And so they really started to think
about disease status and immigration.
In 1987, a nonprofit drug company named Burroughs Wellcome
developed the first drug that worked against HIV.
Initially it had been a cancer drug that had failed.
It had been kinda kept on the shelves at Burroughs Wellcome.
And then in the early 1980s they started using it
against murine leukemia virus, found that it worked.
And within three years, basically brought it to market.
But the cost was extraordinary.
In the early 1980s, the mid 1980s,
it was $10000 to $12000 per year.
Insurance companies, this was before HIPAA,
so insurance companies were just dropping patients
who had AIDS.
And people didn't know how they could afford it.
In fact, the price that Burroughs Wellcome
put on HIV drugs sparked the creation
of a new type of AIDS activist.
The organization ACT-UP was created in part
in protest to the way that a drug company,
a nonprofit drug company, was profiteering off of,
so they thought, HIV drugs and the AIDS crisis.
Well, at the World Health Organization
they weren't focused on drug access.
The gentleman who'd started the program
at the World Health Organization
was a guy named Fakhry Assaad.
In 1986 he died and he was replaced
by a gentleman named Jonathan Mann.
Jonathan Mann focused not so much on drug access
as on removing travel restrictions,
coming up with testing regimens that aligned
with ethics and human rights.
And he started talking about something
called the third epidemic.
So the first epidemic he talked about
was the epidemic of the virus.
As you know, the virus obviously can be latent in someone
for about 10 years before they move to
what we now call AIDS.
They used to call it full blown AIDS,
but it's obviously just the latest stage
of the HIV infection.
But he talked about a third epidemic,
and this was what he was seeing
in all of these different countries
were the enormous social, cultural, economic,
and political aspects of the pandemic.
And so he started thinking
about structural implications of AIDS.
For example, if you want to stop
the reuse of disposable needles
in low income countries and Africa
but the hospital doesn't even have the budget
to pay for penicillin,
it's really difficult to demand that
as a way to help the hospital stop the spread of HIV.
If you're trying to reduce the transmission risk of HIV
in populations that are illegal,
it's very, very difficult as a provider
to talk with people who,
if they came and disclosed their status to you,
would be breaking the law just by doing so.
And so, Jonathan Mann started to think through
how do we address a disease like this?
And at the heart of it, he saw, was discrimination.
And so, he came up with something he called
the public health rationale.
Now, I've written a book about this,
and this is a very, very slow process
which I just shoved into one statement there.
But his idea was that health and human rights,
working against discrimination was a means to an end,
that we wanna stop AIDS,
so the way to stop AIDS is to protect people's human rights.
If we protect people's human rights,
then we can address their either risk for HIV
or the fact that they have HIV.
But he started immediately to move beyond nondiscrimination
because a couple of things were happening.
One is, if you allow, so the at-risk groups
no longer are illegal in a country
but those people still can't afford to buy condoms,
you certainly have helped their social cause
but you may not necessarily do anything
about their disease state or their risk.
And so he began to think about something called
a positive environment.
How does the World Health Organization
create a positive environment in communities
so that they can fight HIV?
And so, he started thinking beyond
just individual human rights to group human rights,
that discrimination falls not only on individuals
but on groups.
And that if you're gonna address those things
you need to think systemically.
You have to support social environments
and you have to explore clinical research that's going on
that might affect these people
and bring these therapies to vulnerable populations.
You also need to think about low income countries
that have discriminated people,
can they even afford
to provide the drugs to their own people?
And he came up with this conclusion
that AIDS-related support would remain inadequate
in a given country if the larger system
of health inequities and inequality remain.
So he started talking about developing structural rights,
that people had a right to a good health system,
a continuity of care, accessible therapies, accessible care,
all of these things.
And this was what he thought needed to be done
to build health systems.
Now, the World Health Organization eventually adopted this.
This was one of the big pushes
that they've had in recent years
is how do we help build the infrastructure in a country
to give them a robust health system?
And this came out of Jonathan Mann's recognition
of the fact that if you wanna fight HIV in a country
that you need to rebuild the health system
such that it can have the capacity to do that.
But as he focused on anti discrimination
as a means to an end,
a number of activists pushed back at him.
He was giving a talk at one point in time,
and he was saying, we need to work to prevent rape,
because women are being raped and they're getting HIV.
And a woman in the audience stood up and said,
shouldn't we work to prevent rape
because women shouldn't get raped?
And he was just taken aback
because he realized that he had this functional view
of human rights.
He was using human rights for a health goal
instead of seeing that the context in which people lived
was oftentimes violating their human rights
and putting them at risk.
And so, he saw the role of women in society
as one of the key things for restructuring the way
that he and the World Health Organization
started to approach HIV.
The Public Health Perspective was,
if we wanna educate women about AIDS,
we're gonna address their lack of literacy by making books
that don't need words.
Now, there's nothing wrong with that.
That's brilliant.
But Jonathan Mann started asking, why can't women read?
What is it about a society that is structured as such
that women don't have access
to the knowledge and education to read?
That doesn't mean we stop making these wordless books,
but it does mean
maybe health interventions include teaching women to read
and using AIDS education material
as some of the ways that they learn how to read.
Because then you're addressing their human rights
and you're not using human rights
as a way to address disease.
You're seeing them as an end in themself
rather than a means to an end.
So one of the things he said was that
starting in late 1980s,
that women needed to be a component
in all interventions planned around them,
whether it was research, vaccine trials, whatever.
Also, gay men, injection drug users, vulnerable populations
that they needed a seat at the table,
that clinical research needed to include
the people who were the object of that research
in the design of those trials,
in the design of those interventions.
And then he started thinking beyond just women
to saying, why were women
and these vulnerable populations in these countries
at greater risk for HIV?
Why were HIV drugs, which by the late 1980s,
it was still just AZT, why were they inaccessible
to the majority of women in developing countries?
And why were the diseases that affected
these majority of women
so understudied and lacking in therapies?
Because as you know, HIV isn't just HIV infection,
but there's all these other opportunistic infections
that come along,
and many of them are endemic in low income countries,
but they're not affecting other parts of the world.
And yet, we had very, very antiquated drug regimens
to deal with those things.
So this became the foundation of something
that Jonathan Mann called
the Health and Human Rights Framework.
It was the idea that the right to health
means addressing the structural barriers
that make people vulnerable to disease,
and likewise analyzing the limits
that this discrimination puts on their access
once they have the disease.
Now, the problem was is Jonathan Mann lived in the world,
and he didn't like his boss, and his boss didn't like him.
So he quit.
He quit right at this moment
when he had come up with this fantastic framework
for how he was gonna approach HIV globally.
And the gentleman who took over for him
thought it was really good
but didn't know how to operationalize it.
So, is that me?
That is me.
My alarm's going off, it's time for me to wake up.
So how do you operationalize it?
So Mike Merson, who's my coauthor in the second book
is trying to think,
we're running this global program, what do we do?
And he went and interviewed Jonathan Mann.
And Jonathan Mann handed him the United Nations
Universal Declaration of Human Rights and said, use this.
Well that's really not helpful.
It may be true and insightful,
but that doesn't tell you how to deal with drug companies
or run a clinical trial
that takes into consideration human rights.
So one of the things Merson started to do
was to work with Burroughs Wellcome.
At the end of 1990, he met with Burroughs Wellcome
and he asked them, can you lower your prices
for these low income countries?
And Burroughs Wellcome said no.
And what they did say was, well,
we would work with you
to address mother to child transmission.
We could come up with a short course
where we would give women who are HIV positive
AZT for a short period of time during their pregnancy
to try and stop HIV transmission to the child.
Well, this poses a bit of a quandary.
Because what Burroughs Wellcome was doing
was being willing to say,
we'll stop kids from getting HIV,
but we're not gonna give the drug to those women
once the kid is delivered and is found not to have HIV.
Well, if you're an international health organization,
what do you do?
Do you say yes or no to that?
Because it seems profoundly valuable to those kids
but profoundly unfair, and it sets an odd precedent.
I'll come back to that in just a second.
But they met later on that same year
to try to get them to drop the drug prices,
and they did so, suggesting that we will make sure
that you have intellectual property protections.
If you drop your prices, we won't let generic companies
come in and create generics and undercut you in the market.
Burroughs Wellcome said no.
They gave them a couple of different options,
and in fact, Burroughs Wellcome came back and said
we will cover a small portion of the country.
The World Health Organization said, well how do we do that?
'Cause if you're only gonna give us enough drugs
to cover 8% of the population who have HIV,
who do we give it to?
How do we decide?
It's kinda the lifeboat thing,
who do you push out of the lifeboat?
And so, the World Health Organization said,
that seems like not a strategy we can go with.
GPA, which is the Global Program on AIDS,
suggested maybe you could do flexible pricing.
In the countries where there are more people with HIV,
you have a lower price.
In other countries where the burden is less
or it's a higher income country, you can have higher.
Burroughs Wellcome said, we're not interested in that.
So the World Health Organization was at an impasse.
What do we do, how do we break this logjam?
They have patent rights, we don't know how to stop it.
I mentioned this, what the World Health Organization did do
is actually say, there's a lot of pregnant women
around the world who are HIV positive,
that's an investment we're willing to make.
And so, they actually did short course trials,
first initially with AZT
and then ultimately with pentamidine
and, what's the other one?
Anyway.
So they did short course trials to ensure
that women who were pregnant in low income countries
could at least get access to prevent the spread of HIV
to their children.
And that was, you know, dramatically valuable
for those countries.
On the other hand, it was hugely controversial,
so much so that some of the board
on the New England Journal of Medicine
quit after an Op-ed came out
saying that this was unethical.
So it remains a very, very difficult case,
one if you have an ethics case sometimes, thinking through,
if you are doing a study
where you give only temporarily people drugs
that then you let them go afterwards
and don't provide them access to.
That's a very, very difficult set of costs and benefits
to try and think through.
But what changed was that a large foundation stepped in.
Rockefeller Foundation, in 1994,
saw that the World Health Organization
hadn't gotten very far with Burroughs Wellcome.
And so what they did is convene
a number of global groups,
including the World Health Organization and UNAIDS
in Italy to try and think if they could create
a public-private partnership
that leveraged charitable money and government money
to fund research with the idea
that those vaccines that were developed
would be sold as close to cost as possible.
And people who joined that effort
had to make those types of commitments.
And then they launched something called
the Global Health Technologies Coalition,
which was a group of 30 nonprofit groups
aimed at addressing the other gaps beyond HIV.
In 1996, you may remember, protease inhibitors came out.
And protease inhibitors were far beyond AZT.
And the disease dramatically changed in terms of prognosis.
All of a sudden, HIV was not something that
you could live with for a while but would ultimately die,
but now people could think of having HIV
and having their disease managed and living into old age.
And this meant that all sorts of countries,
all sorts of organizations,
had a really strong incentive to start thinking
about rethinking global drug strategy.
How do we price it, how do we develop those drugs?
Because we now have a disease that we can manage
that was killing people and now won't be killing people.
But the way to do it is to address the financial needs
that low income countries have
while respecting the intellectual property rights
of multinational drug companies.
And that became the crux of the matter in the late 1990s.
The reason is kind of a global trade agreement called TRIPS,
Trade Related Intellectual Property Rights.
It went into effect in 1995.
Now, it was actually good in a lot of ways
because up until that time,
there was no kind of uniform standards
for intellectual property.
The problem was, high income countries
where a lot of these drug companies were
interpreted this very narrowly
and said, no country can infringe upon a patent
because the patent belongs
to the intellectual property rights holder.
And even if a country's in an emergency situation,
it has to be a very, very rare situation
for that country to be able to overlook the patent
and get the resource, whatever it is, into its population.
Well, low income countries didn't like that.
And so, the Doha Declaration came out in 2001,
and the World Trade Organization ultimately agreed
with low income countries.
It was part of the 2001 trade talks.
And it recognized that in the writing of TRIPS,
there were flexibilities
that member states could,
in situations of national emergency,
take over a patent to use it for their needs.
This gave countries the right to determine
what the national emergency was.
And it expressly included diseases
like HIV and tuberculosis and malaria.
And when they drew up this Doha statement or declaration,
they drew on health and human rights as the rationale,
that human rights trumps patent rights.
And therefore, countries have the right to be able
to do something for their people
even if it violates international patent law.
So this has transformed the way we think about
global access to drugs.
Now, we still have problems,
but a lot of things have changed.
One is the leadership at the UN agencies changed.
And then the Rockefeller Foundation had set this example
that started to get picked up.
As well, social conservatives, political conservatives,
at the end of the 1990s and the early 2000s
really started to see that this global pandemic
was something that they needed to get
and engage political will to do something about.
The Clinton administration actually came to its senses
and recognized that it had been promoting these TRIPS rules
that really closed the aperture on patents,
and they had played a part in restricting access to drugs
to these low income countries.
And Al Gore wanted to be president,
and so he spoke at the United Nations Security Council,
but what was important was he called AIDS
an international security risk.
He recognized that with HIV
disproportionately affecting low income countries,
that it created situations of chaos and turmoil
that then would create political instability.
And therefore, the world had both a moral and ethical
but also security rationale for doing something about AIDS
and other diseases.
So pharmaceutical companies
started to face a lot of pressure.
If this Doha agreement is out there,
that countries can seize their patents
in cases of national emergency,
and international countries and organizations
are starting to see AIDS
as actually an international security issue,
then we should probably do something
to pick up our image a little bit.
So what changed?
Well, the Gate Foundations started in 2000,
and they made their commitment
to addressing HIV and other diseases.
And in fact, they took the Rockefeller Foundation model
and applied it not just to HIV
but to other diseases that needed vaccines and immunization.
And the GAVI alliance has been really profound
in coming up with vaccines that have addressed
diseases all around the world,
in part because they've leveraged
and created efficiencies in generic vaccination development
in low income countries
such that vaccines are able to be distributed in countries
where they never had real access to them before.
The other thing that happened
is the Gates Foundation and other groups
created something called the Global Fund.
The Global Fund focused on malaria and tuberculosis
as well as HIV.
Malaria and tuberculosis
had really come back into the picture
because they were third world,
or developing country diseases.
And so, developments on malaria and tuberculosis
had really lagged.
High income countries
didn't really struggle with those problems,
so they didn't really need to do very much about them.
But with HIV, all of a sudden,
resistant tuberculosis and malaria were really severe
and needed to become addressed by Western countries,
both in their own countries and obviously globally.
And so, the Global Fund was set up
to be this huge pool of money to spur
interventions and research in these areas.
PEPFAR was also created in 2003.
PEPFAR was a huge and important step,
both because it targeted
14 of the most hard-hit countries with HIV,
but it also focused on two things.
One, getting drugs to those countries
and rebuilding the health infrastructure in those countries
so that the health system was available
to address those needs.
But there started to be a lot of pressure then
on drug companies
to do something about the prices of their drugs.
All of a sudden, you've got the US government buying drugs,
they wanna get the best bang for their dollar.
And Bill Clinton, oh whoops, sorry.
Bill Clinton, who had felt guilty
for some of the work he'd done
protecting international patent rights
started working through his foundation
to try and find ways to get flexible patent rules
in low income countries.
The World Health Organization had gotten in a fight
with the UNAIDS after UNAIDS was launched,
and so it had actually stepped out
of fighting global AIDS for a long time.
But in the early 2000s it came back
saying, this is something that we will commit to.
And so, in the early 2000s they had the three by five plan,
which was the idea of getting drugs
to five million people by 2005.
And that meant that all of a sudden
you had a large organization trying to focus
on streamlining and reducing costs and distribution.
And so, drug companies started to feel the pressure
and wanted to get on board.
If you can, create an economy of scale.
For these drug companies, all of a sudden
it's in their best interest to reduce the cost
as much as possible.
So what these entities were doing
was de-linking the production of drugs
from the cost of those drugs.
And the health and human rights framework was saying,
we need to somehow come up with a way
to de-link the costs of R and D from the cost of the drug.
And so, drug companies actually started
to create their own unique ways
of delivering care in countries.
Merck had started this back, focusing on River Blindness,
and other companies started to recognize
this is something we could do as well.
It doesn't mean
that we're just giving our drugs away necessarily,
which Merck had done with River Blindness,
but we could start to come up with programs
in hard hit countries
where we get these drugs to people,
because they're gonna be taking them
for the rest of their life.
We need to come up with a way to address
the economies of scale.
At the same time, UNAIDS came up with its global program.
I won't go into all the details on those.
But we started to see globally
a huge success in addressing HIV.
The World Health Organization, seeing this success,
decided, you know, we could create
kind of a stakeholder group
to think about other diseases
that are hitting other countries
as hard as HIV was hitting these countries.
And we should start to become a catalyst
to focusing research.
And in fact, the international community built
addressing research and development for drugs
in their millennium goals.
So, I already mentioned that we still have
two billion people and 30% of the global population
lacking these diseases,
but we've seen, interestingly, in the past two decades
some really strong movement
towards addressing some of these things.
It doesn't mean we're out of the woods.
And the reality is drug companies
still have a lock on a lot of the drugs
that are necessary and out there.
But one of the things that's happened
is that people have focused on accountability.
Not necessarily naming and shaming,
but at least highlighting what drug companies are doing
and the extent to which
they are making their drugs available.
And each year now, many companies
are starting to come up with strategies
to try and provide access to these essential medicines.
So this comes from the Access to Medicine Foundation,
which every two years puts out a report
on which drug companies are doing something.
GlaxoSmithKline has, for the three reports, so six years,
been at the top of those.
Partly that's because after 2001
they had a tremendously huge scandal
and fired a whole bunch of people
and hired a doctor who decided
he was gonna run drug trials in transparent ways.
And this was one of his things,
is let's get drugs into the hands of people.
The other thing is, we've started to see
a number of partnerships, public-private partnerships
to develop.
So Merck obviously, as I mentioned,
had basically donated its drug to fight River Blindness.
But now we have public-private partnerships
for medicines for malaria,
there's the One World Health Institute
which focuses on neglected diseases,
the European Union has an Innovative Medicines Initiative,
there's something called
the Drugs for Neglected Disease Initiative,
and it has garnered $290 million over the past decade,
which means that the drugs
that get developed from those things
get sold at cost
because they don't have any need to recoup R and D prices.
And then there's something called the European Lead Factory
which focuses on waiving fees for nonprofit groups
that are fighting,
so they're basically a CRO that's run by the European Union
that tries to find promising drugs
and get them to market as soon as possible.
And if you're a nonprofit group,
they waive all sorts of fees
so that the cost, when it comes to market,
sells at a low price.
There's also all sorts of unique ways
of doing partnerships, developing partnerships.
Some are closed, so if you buy in
you get to reap the benefits.
But increasingly, they're moving towards
what are called open collaboration partnerships,
depending on the needs of the community.
Doha gave something called Compulsory License Flexibility.
And countries have tried to use this.
Kenya is the most obvious one,
they used it to fight HIV in their country.
Brazil did the same thing,
where they just grabbed the patents
and started producing protease inhibitors.
India did the same thing,
and ultimately created generic drugs.
So some countries have taken the patents of drug companies
and said, we have such a national emergency
that we are gonna try and combat
the high price of these drugs in our country
by seizing the patents.
It gets sued.
Sometimes the United States has backed the drug company,
other times they've backed the country.
But the point is, is this mechanism is there.
And a lot of researchers look at this and say,
this is kind of low-hanging fruit.
Countries should look at the largest disease problem
in their community
and either use Compulsory License Flexibility
or other mechanisms like parallel tracking,
which is to create a parallel track
that the government creates its own generic medicine
that it provides until the drug company drops its prices.
I have this little march-in thing here
because here in the United States
we actually have something called march-in rights,
which within the Bayh-Dole law back in 1990
about drug development
said that if the country needs to,
the NIH can actually step in and pressure a company
to use its patent or deliver it to someone else.
And it's been debatable, for example,
with situations like insulin,
if a company is price gouging on insulin,
can the NIH step in and say,
until you lower your prices,
we will give the patent license to someone else?
So far, it hasn't been able to succeed,
in part because the head of the NIH has said we can't do it.
We happen to have a Commander in Chief right now
who doesn't like to necessarily follow rules,
so this'd be a really great opportunity
for the Trump administration to lower prices
by using march-in rights
against people who are doing price gouging.
That's my just, political commentary there.
But there's other things we can do.
There's new funding innovations that are out there.
One of them is, is that countries become investors.
So a country that's hard-hit,
maybe at a stage III in drug development
actually could help partially fund the drug trial
in response for when the drug comes to market,
that country gets lower prices
than what the market would bear.
And so, there's some movement in this area.
The other thing is, states like California
are actually looking at creating
their own generic drug industry,
so that what they do is target generic drugs
that are costing their state
through their Medicaid program too much money
and actually start to produce those themselves.
California's even thinking about selling to other states
if they get the rights to actually do this.
So, just so you know
in case Texas wants to come up with something.
All right, I'll end here.
But we have a long way to go in these areas.
There's a lot of gaps.
But the health and human rights perspective
has started to see that people are ends in themselves,
and that patent law, patent rights
don't trump human rights.
And so, this health and human rights mechanism
that came out of the HIV movement
has started to push countries, organizations, entities
into rethinking how we do drug development,
and pushing back against some of the rules
that drug companies have set up.
So they're merging models of thinking
about pricing, partnerships, and patents
that ultimately de-link
the funding of research and development
from the cost that goes to the people in the market.
I wanna just highlight one last thing.
I'm not supposed to walk.
But I picked up the Wall Street Journal on the way here,
and this is the front page today.
Drug makers test new models to pay for costly treatments.
So the reality is, is that even drug companies
are feeling the pressure to do something about the costs,
whether it's globally or locally.
And thinking about health and human rights
as it applies to clinical research
is a way of trying to create a movement
towards health for all.
I'll just take some questions.
I guess I'm supposed to, the VA?
Okay, thank you.
(clapping)
Do I take selects before I take the VA, or?
Are there questions from the VA?
Selects on.
So, did everybody hear her question?
One of the things she talked about is the,
obviously increasingly we have international drug trials
and drug development.
While the companies are doing international trials,
the companies themselves are usually not based
in those countries,
although in India and China there are certain ones.
Japan, actually, is the second leading.
The real question is, and this has been the challenge,
is who owns the patents?
A lot of you are doing the basic research,
maybe not necessarily all of you,
but here at an institution like this,
a lot of the basic research is being done
that lays down the foundation that then gets capitalized on
by international companies.
And one of the things that the United States has focused on
is how do we tag into licenses and force companies
not necessarily to operate in ways that exploit
the end user.
And that's a real challenge,
because as international companies
develop drugs in other places,
actually, the Trans-Pacific Partnership,
which passed under the Obama administration,
and then the Trump administration pulled out of,
it actually had really strong protections for drug companies
so that no one could come in
and seize some of those patents.
And that's a real challenge.
Now, to that end I think the Trump administration
pulling out of the TPP was fine.
The point is, is I don't think most people think
that the Trump administration is going to come and say,
you know, we should have open patents to everybody.
That's not the reason they pulled out of the TPP.
But there are some concerns,
when they're developing in other countries,
to what extent do we lose control over leverage
to do something about those things?
And that's where TRIPS comes back in, and the Doha agreement
and the extent to which,
part of it is an act of will, too.
If the United States decided to defend countries
that were in national emergencies
trying to address the needs of their population,
they could go to the WTO on behalf of those countries.
And that's really a political will.
But oftentimes we go based on our companies
that have the patents in our areas,
and so that's been one of the crises in the past.
So, and it obviously depends.
Some protease inhibitors are now off patent.
And so, if that's in the public domain,
then a generic company in India,
and actually, India is some of the earliest fights
both against AZT and other things.
The companies will sue,
and they'll sue with the World Trade Organization
or they'll sue,
depending on where the country is originating.
And many times the companies have won
based on international intellectual property rights.
But I don't know in this particular situation.
But conceivably, if they're, you know,
using somebody else's patent illegally,
or outside the rules, they may well be stopped.
But that hasn't, Brazil did the whole,
they basically gave drugs away
and they said, fine, sue us.
Go ahead and sue us,
we're gonna give protease inhibitors to our people.
Correct.
'Cause the rule is, and we obviously know this
even with the Trump administration right now,
they're talking about re-importation of drugs.
The fear the drug companies have
is that if you can make a low-cost drug in Zimbabwe,
that somebody'll just take a big airplane to Zimbabwe,
buy all the drugs there,
and then fly back to the United States.
So drug companies recognize
that in a global society they wanna,
one of the challenges is though,
some of these drugs actually cost more in those countries
than they do, not necessarily in the United States,
but some European countries.
You can actually go to Mozambique or someplace like that,
and some of those drugs will cost more there,
either relative to people's income,
or in actual fact, they'll cost more there.
So one of the things is creating
some sensible sliding scales
for how drugs can be sold in developing countries.
But that's gonna take the World Bank
and the World Trade Organization
and countries like the United States
actually acting for health and human rights
rather than for company profit.
And that's a real difficult thing.
So that's the TRIPS agreement and the Doha Declaration.
Not the universal, the UN doesn't have that
in the Universal Declaration of Human Rights, no.
And that's, so low income countries have said
that, well, the TRIPS agreement says
countries get to declare what constitutes
a national emergency.
What other countries have done have pressured them not to.
So Columbia, for example,
was going to declare a national emergency,
and the United States and some other countries
where the drug companies were housed
basically threatened trade punishment against the country
if they did that, to protect them.
So a country can set its own national emergency.
Most people won't do it if it's not,
you know, if it's 0.5% of the population
they won't see that.
But I mean, you can think about some of the countries,
particularly with HIV and others,
where 20%, 30% of the adult population.
That seems like a national emergency to me.
But the Doha principles weren't in place at that stage
for them to do that.
Right, and that's the concern.
Yeah, he's dead so that'll be tricky.
I'll try and answer it for ya.
No, a lot of people are drawing on both of those.
Although, the US has only ratified one of those.
And so, because of that then they say
they're not bound by it,
and that's one of the tricky components of it.
But yeah, Larry Gostin and a lot of folks
in the health and human rights movement
have really drawn on those things
and actually clarified them in more recent years,
in part because they're very, very vague
and not operational.
So that makes it a little bit difficult.
But if the United States, back in 1966,
and so there was some implication by Southerners,
as you can imagine, that adopting those things
might mean that then, you know,
Jim Crow would have to go away.
And you know, so the United States didn't sign
all of those themselves.
So then they say they're not bound by those.
Oh, we're done.
Oh, I'm sorry.
Oh, so you can ask questions up here afterwards
but I think we're done.
Thank you. (clapping)
Thank you.