January 17, 2023 • 40 mins
Tim O’Brien is not a scientist. But he is a user of Covid-19 vaccines. He thinks they’re miracles, and the single biggest reason the pandemic wasn’t more devastating. But if that perspective makes you erupt, please relax: Crash Course is focusing today on the companies that make the vaccines, not the science. And Tim has a question: Have those amazing innovators – those life-savers – played fairly when it comes to sharing the financial spoils of their miracle drugs? And they were miracles. Just about nine months after the US went into lockdown in March 2020, the first vaccine jabs were available. There are a handful of marquee companies that won that race, Pfizer, BioNTech, Johnson & Johnson, and AstraZeneca among them. But today, for purposes of a lively discussion about innovation and avarice, Crash Course will focus on Moderna, which is a useful proxy for examining how a groundbreaking vaccine was unearthed – and who got control of its uses.
To do that, Crash Course has invited Dr. Monica Gandhi, a leading virologist and epidemiologist who also teaches at the University of California San Francisco, to join our podcast.
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Episode Transcript
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Speaker 1 (00:02):
Welcome to Crash Course, a podcast about business, political, and
social disruption and what we can learn from it. I'm
Tim O'Brien. Today's crash Course COVID nineteen vaccines versus the
bottom Line. I am not a scientist. Repeat, I am
not a scientist, but I am a user of COVID
(00:22):
nineteen vaccines. I think they're miracles and the single biggest
reason the pandemic wasn't more devastating. But if that perspective
makes you erupt, please relax. I'm focusing today on the
companies that produced the vaccines, not the science. And I
have a question. Have those amazing innovators, those life savers
(00:42):
played fairly when it comes to sharing the financial spoils
of their miracle drugs, and they were miracles. Just about
nine months after the U S went into lockdown in March,
the first vaccine jabs were available. There are a handful
of marquee companies that won that race, Visor by Tech,
Johnson and Johnson and Astra Zeneca among them. But today,
(01:05):
for purposes of a lively discussion about innovation and avarice,
I want to focus on moderna. It will help keep
our conversation on point and MODERNA is a useful proxy
for examining how a groundbreaking vaccine was on earthed and
who got control of its uses. And to do that,
I've invited Dr Monica Gandhi, a leading virologist and epidemiologist
(01:27):
who also teaches at the University of California, San Francisco,
to join our podcast. Hi Monica, Hi, thank you. It's
great to see you and to talk to you. So,
first tell our listeners a little bit about yourself. How
did you end up devoting your career to battling some
of nature's most dangerous stalkers viruses? You know, Actually my
(01:51):
entire interest in viruses came about when I was quite young.
I was only twelve, but it was when the HIV
epidemic was first reported. I got fascinated by that. Yeah,
it was one June, to be exact, were the first
case reports of these devastating infections, and usually young men
(02:11):
who obsessed with men. It was out of the blue.
It felt horrible, And what struck me, even at that
young age, is that viruses or other bacteria or others,
fungi or others, parasites are others. There's us as humans,
and then there's pathogens. That attack us. And when you
say others, you mean like intruders exactly, intruders that come
(02:34):
from the outside and really have nothing to do with us.
And we have strategies, or at least have developed strategies
over the years of technologic advances to fight the other. Well,
go back on what the hook was for you. You said,
you know, you described them as outsiders or invaders. Do
you see yourself as sort of a detective Yeah, I
(02:57):
like that idea. I think scientists are detectives because is
by the way, we're going to be getting more viruses
and and the planet is changing, and but it is
sort of detective work. And then it's this idea of optimism.
And I think that's what appealed to me at the
age of only twelve, is that it's optimistic to think
that we have the technologic tools and we can develop
(03:19):
them if we work hard enough to fight all these
pathogens coming our way. And I was amazed by the
optimism of infectious disease. I really have to tell you
that if you meet any infectious disease doctor, they have
a sense of optimism. We're going to get this, we're
going to fight it, we're going to figure out how
to combat it, and that's what happened with so many viruses.
(03:39):
That's not a bad way to live. It's not a
bad way for you to live, a very positive way,
enjoying solving mysteries and feeling hopeful about the outcome. Helpful
exactly right. Well, so let's talk a little bit about Moderna.
It's a pretty spectacular company, right. Can you talk a
little bit about its history if you would, in the
development of m RNA vaccines, Yes, So, just to be clear,
(04:01):
MR and A vaccines by the way, it's not like
they're brand new. You know, a lot of people say, oh,
there was no such thing as mr anda vaccine technology. Actually,
remember we've had three major coronavirus is come out and
cause severe disease in the last twenty years. The first
one was the stars pandemic two thousand to two thousand three.
The second one was merrs. All these are coronaviruses, and
(04:25):
that was the time with mers that the mr and
A technology was pulled out. It was already an idea
developing that you take instead of part of a virus.
Because we all got dip theory of vaccine, tetanus vaccine
protusses vaccine, and you know what we got. We got
a piece of the protein of the virus put together
(04:46):
with something called it adjument, and that made us raise
an immune response. But the mr and A technology is
to give the recipe for that piece of protein, not
the protein itself, but the recipe book for you, the
human body, to make up the protein in higher levels
so that you raise really vigorous and importantly a strong
(05:06):
immune response. M RNA goes away, the protein goes away,
but you have that immune response to live with. And
so this was a technology that really started way before
this pandemic, in the mirrors pandemic, but we didn't need
it because Morse sort of dwindled out. I mean, we
sort of got lucky escaping stars and mirrors, right. We're
fortunate to a certain extent that stars and mirrors didn't
(05:28):
become what COVID nineteen became. Yes, I mean, it's really
an interesting question. I mean, they didn't spread in the
same degree before you had symptoms, so you knew, you know,
when you had stars, and then you could isolate those
individuals and then fundamentally, actually they did make people very
sick and very unfortunately, and so we could again isolate
(05:49):
and they just sort of dwindle. Both of them went
away without the need for vaccines. But COVID nineteen we
were never going to get away with that. And so
in the wake of Stars, this little company that calls
itself I think originally modified r n A and then
they shortened that into Moderna opens its doors up in Cambridge, Massachusetts.
(06:10):
Exactly not a new technology. This Maderna company started in
two thousand and ten. So you know, remember that, like
it wasn't that this is some brand new technology. We
wanted it to have a company that would be focused
for the next pandemic. As SARS went away in its own,
Where's went away on its own. The idea was, if
we ever had a pandemic, Maderna and other companies like
(06:33):
this would lie waiting with this novel technology. And Maderna
was doing cool things and has done cool things. How
was it looked upon or received within the both the
research community, the public health community, the greater kind of
commercial pharmaceutical community. What did people think of Moderna in
(06:53):
its early days? It was looked on very favorably because
it was this little company that could and it was
just really trying to work on, for example, cancer vaccines,
human metanuma virus, thinking about using this for influenza, for ours, fee,
for all these other viruses that we've been having, and
I don't have a vaccine yet. But to be honest,
it wasn't very well known. And then it was sort
(07:16):
of chugging along and chugging along, and then reality turned
it into a star in the broader idea of innovation
in the pharmaceutical world. I mean, how hard is it
to authentically innovate to really produce knockout revolutionary drugs. Actually,
this is a great question because in the history of vaccinology,
(07:40):
we have these kind of basic ideas, right, Like smallpox
was the first vaccine that was thought about. And what
they did, Edward Jenner, was take another virus that looked
like smallpox, vaccinia and also cow poxies are cousins of smallpox.
They're also cousins of monkey box by the way, and
put a little bit of that into humans. Put a
(08:02):
little bit of a related virus into humans. So that
was the first vaccine technology. And then when we went
around in time, it was like, wait, I don't want
to give you a live vaccine, you know, from even
a cousin. I don't want you to get that cousin.
So let's think about putting pieces of the virus, innocent
pieces of the virus, not the whole virus, Innocent pieces
of the virus linked together with an adjuvent. Or we'll
(08:24):
give you the whole virus, but we're gonna kill it,
We're gonna inactivate it, or we're gonna at least make
it very weak. And these were all the viral technologies
we had. The idea that mcderna, who started in two
thousand ten and was working on MR and A technology
two thou seventeen and then the knockout in two thousand
and twenty, the idea that we have this totally novel
vaccine technology for our next pandemic was amazing because the
(08:51):
vaccines that we have work well, but we needed a
vaccine that worked really well. This is a worldwide pandemic.
Then we should, I think, probably be grateful about the
level of high quality innovation that exists within the biotechnology
and the pharmaceutical community. Yeah, I totally agree. Yeah, And
and it's rare, it's really rare to get one of
(09:13):
these drugs that's like a Grand Slam, A lot of
money gets poured in, a lot of research gets poured in,
but there can be misfires, right, Yeah. And actually, to
be very fair on what you said, I should say
that I've been in academia all my life. I'm an
n H funded researcher, and i know the NH very well,
and I know universities very well. But really, for knockout
products like this, we do need to work with our
(09:35):
biotechnology and pharmaceutical industry colleagues. Really to make immunotherapy for cancer,
to make cancer vaccines, to make a Marni vaccines, we
need a company that has the innovation and also the
funding in it and the production capacity to make products
at scale. So this is a major link that we
(09:57):
have between academia and industry our novel rugs, and we
need them. And and there's a third link, isn't there
the federal government and the deep, deep pockets of Uncle Sam.
Because the trajectories of these drugs are so long, the
risk in whether they'll even come to market is so high,
and the cost is so exorbitant that when companies can
(10:20):
a partnership with the federal government is often very useful. Right, Yes,
And it's a great question that you asked, because it's
not just the n I H that would maybe say
fund a research innovation, but it's the f d A
that helps work with companies to say, really, if you're
going to produce this, we're going to help work with you,
and we're gonna get it out quickly. We're going to
(10:40):
approve it more quickly. And it's also was very unprecedented.
But Operation work Speed in this setting of sarce COVID
two was really the federal government saying, okay, look, we
have a novel virus. Life has you know, ground to
a stand still worldwide. We need to get out of
vaccine quickly, and we're gonna independent funding and invest in
(11:02):
a private public partnership. And that was innovative. We have
to give credit to Operation Warp Speed and Moderna was
a direct beneficiary of that that the head of Operation
Warp Speed had been on Moderna's board. MODERNA got I
think around ten billion dollars in federal funding to help
it do R and D around m R and A,
and I think it had a partnership with the federal
(11:22):
government that lasted for at least I think four years
prior to bringing their vaccine to market. How do you
see Moderna's role during the early stages of the pandemic
When you think about the importance of MODERNA as an
entity at that time, you know, I see Maderna as
extremely important at the in the early phases of the
(11:42):
pandemic because everyone was rushing to make a vaccine. But
there were sort of eyes on Maderna because in two
thousand and seventeen, Madderna had developed a prototype of an
mRNA vaccine four different viruses, including human metauma virus which
causes is a sort of a respiratory viral syndrome every
(12:03):
winter in people. And so there had been an immediate
look at this novel technology of Maderna. To be fair,
and I'm sure that people know this history, but the
Vaccine Research Center, like you said, the federal government had
already funded Maderna and been involved in Maderna. So Barney Graham,
as the lead scientist at the Vaccine Research Center at
the n I AGED had been involved in the mRNA technology,
(12:26):
really helped co develop it. So it wasn't just a
financial relationship, it was also a research and development relationship. Definitely,
definitely a scientific relationship because Berney Graham had already written
a paper just the year before in Nature magazine that said,
if we ever have a pandemic, we have to have
the vaccine as fast as possible using novel technologies, which
(12:48):
was obvious. I mean, he's reflecting what we're all thinking,
is that if we get a pandemic, unlike influenza, where
there was no vaccine, it went away because fortunately a
lot of people died of the virus, it went away
on its So was the first influenza vaccine ever developed.
So it didn't go away through technology. And so we
(13:10):
knew from nine that this time we couldn't let her
go away through natural immunity and through more mortality. We
needed to help quell the mortality through vaccine technology. Monica,
I want to ask you more about the partnership between
MODERNA and the government. Well, let's take a quick break
from a word from one of our sponsors, and we'll
(13:30):
jump into some of the patent battles when we return. Okay, So,
Dr Monica Gandhi and I were just talking about the
relationship between the federal government and pharmaceutical companies, and the
federal government and MODERNA specifically as being one of those
useful private public partnerships that helps bring things to market
(13:55):
more quickly and ideally with better outcomes. And Darren is
sort of the post your child for an outcome like that,
isn't it Monica? Yes, because close ties between the n
i H and Maderna R mad had developed a novel
technology with the help of the NH and the Vaccine
Research Center at the NH with Barney Graham, and it
was almost poised to be the company that brought us
(14:17):
the vaccine for COVID. Do you recall where you were
or how you heard about the idea that there was
going to be a popularly available vaccine that could not
COVID nineteen off of its heels. Oh, I remember very
rough because even though December eleven was the first u
(14:39):
A for the vaccine in the United States that was
through FISER, November nine was the first time that we
got the results from FISER and November sixteen was the
first day that we got the results from Maderna. This
is two thousand twenty. I was thrilled the results were profound,
just this incredible level of protection against automatic COVID with
(15:01):
both of these mr and A vaccine products. A lot
of talking to the press around that time, just I
was sort of really very excited and very thrilled. I
just couldn't believe it was so fast. November nine after
March eleven, that's less than nine months. It's amazing. Eight
months ago we got the results, nine months we got
the product to you. When people used to talk about
(15:22):
drug development taking years, right exactly, I just I couldn't
believe it. I felt like it was a day like
going back to my history and why I was so
interested in virology, where everything was full of hope, everything
turned around. It was that optimism and we got it.
That's all I cared about. Well, and you know, you
(15:42):
mentioned the influenza epidemic of a century before and how
they just basically waited it out and had to let
the bodies pile up because they lacked the science. They
lacked the innovation then to be able to combat it.
And that is a hallmark of progress in our era,
isn't it? Thinks Actually, I mean I have also because
I'm really interested in infectious disease. I've really read a
(16:04):
lot about a history of infectious disease. Prior to the
development of new technologies, we had to wait everything out,
and we waited it out through misery and through death
and suffering. And the same was true of HIV at
the beginning of the pandemic, before we got the novel
and treach of our therapies. It was terrible, but we
didn't have that technology. And I don't know about other industries.
(16:26):
I'm sure this people think the same thing and energy
and other things. But I knew that we can never
have another pandemic again where we didn't have technology waiting
in the woods to essentially control it. Otherwise the death
and suffering would have been much much more. We have
had almost seven million deaths from COVID nine team worldwide.
That is unacceptable, but it is so much less than
(16:47):
we would have had. You know, there was this very
spirited debate around a lot of the different drugs and
vaccines that came onto the market during the early days
of COVID, around whether or not they were fast fairly
and whether or not everyone had the access to those
drugs that needed them, And it sort of became this
(17:08):
interesting discussion about both innovation and I think miracles and
avarice and overreach and justice. Yeah, and I wonder if
you have any thoughts about how you think about that
around any of the big pharma companies or the small innovators. Well,
this is a great question because I'm really a student
(17:30):
of HIV history in the sense that I grew up
thinking about HIV a lot. And when you look at
the history of HIV, there were incredible innovations in HIV
which were really the anti viral therapeutics that were developed
and disseminated in the US and Europe. By in the meantime,
HIV was raging in Sub Saharan Africa and India and
(17:53):
Eastern Europe and other places that actually didn't have access
to these medications, and it became a global and very
visible fight and advocacy from the HV community, from scientists,
from clinicians, from researchers, from patients that said, wait, how
can we save the lives of only one group of
people when we have novel technology and not that saved
(18:15):
the lives of a whole other group of people because
they live in lower income nations. And the two thousand
International AIDS meeting, which is in Durban, South Africa, it
was just fiery and it was all protest. It was
people from the U S and Europe saying I'm not
taking these medications until my brothers in South Africa can
get these medications. It was very, very vocal and very visible.
(18:37):
We were horrified that the innovations would not be given
to low incombinations. Well, generally, how do the drug companies
respond to protests like this or criticism of them about
the availability and access to their drugs? So sometimes very
ignore the communities, and then sometimes they're very responsive. So
(18:58):
what happened is the year two thousand when the International
AIDS meeting was drowned out by the Dinner protest. Really
what happened is that Fiser at the time was making
a very cheap medication called flu connisol, which would combat
cryptococ commeningitist, which is a very high mortality opportunistic confection
in AIDS, and they made a billion dollars in the
(19:19):
year two thousand from flu connisole. And it just seemed
unconsciousable that we'd have this very cheap drug that should
be could be made by generic companies and marketed to
the rest of the planet, and Fiser was making that
much money. And they did respond, and there was a
process that occurred through the World Trade Organization, the w
(19:40):
t O called the trips waiver, and what the w
t O meant at the time is that if we're
in the middle of a massive global health emergency, patents
may not matter to the same degree as they would
and we may have to waive those patents through the
trips waiver to a allow companies in South Africa and
(20:02):
India and kind of middle resource nations to get the
formula and to make these medications more cheaply and to
give them out to low income resource nations. And that
really occurred as a result of HIV and equity. You
bring up patents, which is another sort of leg of
the stool and watching I think how pharmaceutical companies protect
(20:23):
their research, protect their products, but also protect their bottom line.
You know, there's a lot of patent battles that occur
in the pharmaceutical world. Patent trolling is a big thing
in big pharma. Talk a little bit about that. How
much of the patent battles are over really legitimate claims
to intellectual property, and how many of them are anti
(20:44):
competitive or are simply used to sort of protect something
that might have a more generic use. So to be fair,
the reason that patents came about, obviously is that the
company would say, you know, we need to make money
off of our products because put in a lot of
research and development into our product, and that comes money.
In this case, of course, the operation Workspeed had invested
(21:06):
ten billion dollars from the US federal government into the
Maderna vaccine. But under more normal circumstances where we're not
in the middle of a global health emergency, usually it
is the company itself that's come up with that money.
And the point of protecting patents is to say, we
need to spend some time and tell the medication naturally
becomes generic, because after a certain amount of time, every
(21:27):
medication is allowed to be made by generic manufacturers. The
companies would say, it's we need this patent to protect
our profit and I do understand that again under normal circumstances,
but these aren't normal circumstances. Well and moderna there's even
an extra little twist in all of it, because what
did it do after it engage in this sort of
(21:48):
mutually effective and profitable partnership with the federal government to
develop a vaccine, bring it to market, and start to
reap the financial gain of that, including a skyrocketing stock price.
It began to threaten the federal government with a lawsuit.
It said it was going to take the government to
(22:08):
court under the claim that it had soul rights to
the patents around its COVID nineteen vaccine right right. So
that was a very surprising day because not only had
the government invested from Operation Warp Speed into Maderna, and
not only had the government, through the Vaccine Research Center
at the NIH, helped contribute to the technology scientifically with
(22:30):
Dr Graham and his research associates, but finally the government
had actually agreed to give Maderna and Feiser the money
and pay for the COVID vaccines because we're in the
middle of a global health emergency and a US public
health emergency. So instead of people having to get this
through their insurance, we made this vaccine widely available in
(22:50):
pharmacies for everyone, whether they have insurance or not, undocumented immigrants,
doesn't matter. You can go and get it at a pharmacy.
But how can you go and get it a pharmacy
because a government purchased these vaccines from Maderna. So to me,
I was shocked because it seemed like Maderna had had
plenty of investment from the federal government and I mean
(23:11):
the whole idea of the intellectual property from Dr Graham
was ignored and they sued the federal government. And I
will just tell you as someone who's NIH funded, I
would be on calls and people at the n H
were very frustrated and shocked. Well, Moderna ultimately backed away
from those legal threats, but they, you know, they also
had interesting arguments. You know, when Moderna would be sued,
(23:33):
they would argue on occasion that the federal government had
to defend the lawsuit because it was the federal government's product.
But when it came to this patent battle, they wanted
to claim it as their own. Doesn't seem like they
can have it both ways though, there, you know, right,
And I think Moderna was also sued Visor and bion
Tech for patent infringement, and Moderna itself has been sued
(23:53):
by other competitors. It becomes this big tangle of patent
battles that can often obscure or you know, what people
want out of the drugs themselves and how to bring
them to market effectively. Yes, I think it makes the
company's look really greedy, like you said, because actually both
Madonna Adviser have made a lot of money during the pandemic,
(24:14):
and it makes them look like they're not responding to
equity concerns about how we give these vaccines to low
income countries, and it just it's not like we're not
going to use these products. But it did frankly leave
a lot of people in the scientific community called. Okay,
I think we should take one more break here and
um when we get back, I want to talk about
(24:35):
the effect that moderna has overreach has had bringing vaccines
to the rest of the world, and that will come
up after these ads. We're back with Dr Monica Gandhi, who,
by the way, you can pre order her new book, Endemic,
a post pandemic Playbook. It will be published this summer.
(24:56):
I will be an eager reader, as I'm sure many
other people will be. My Nica. We were talking just
before the break about these internet signed patent battles in
the US and Western Europe, primarily I guess some parts
of Asia over control of vaccines. But what are those
sort of battles ultimately mean for low income to moderate
(25:20):
income countries, primarily those in the southern hemisphere where they
lack the public health infrastructure and the private public partnerships
to deliver these kind of drugs to their own citizens.
What do these battles mean for them? So it means that,
you know, residents of those nations lose out, and it's
(25:41):
really unfair. So to just clearly lay this out. India
and South Africa had not really suffered from COVID that
much by October of because we still hadn't gotten into
the new variants essentially, but there was an anticipation that
we would have new variants. We'd already had one called
D six fourteen G and so they were smart enough
(26:02):
to say, well, just because we've been relatively spared so far,
it's not like we're not going to need these vaccines.
We see the writing on the wall. You're developing these vaccines,
and they wrote a letter. Indian South Africa wrote a
letter to the World Trade Organization in October saying something
bad could happen, we could get a new variant. It's
not like we're going to get through this without vaccines,
and please invoke the trips waiver to ask Maderna and
(26:26):
fiser or who are developing these vaccines. And we got
the data just a month later to waive the patent,
so that we can make these m RNI vaccines in
our nations, and why is it Indian South Africa because
they basically have the ability to make these vaccines. They're
kind of middle resource countries. They have already shown that
they can make gantredge of our therapies and other medications.
They had the technical capability. They said, please invoke the
(26:50):
trips waiver to the w t O so that we
can make the vaccines as soon as they're ready. W
T I said no, And in the meantime we had
an election and Maderna and Fiser wrote letter to President
Biden assumed as he was elected and said, you know
that letter from India and South Africa, that's a really
bad idea. Don't do it. And so unfortunately Biden for
a while did not actually support the trips waiver, and
(27:14):
we got well into some very bad times, specifically the
delta variant in India with a four percent vaccination rate
in March. And then why did the w t say no?
Because you really do need support from the world community.
It is the World Trade Organization and fundamentally it is
partially dependent on G nine nations and eventually, I hope,
(27:37):
would hope G twenty saying these high incombinations supporting the
trips waiver because obviously these nations are getting pushed back
from the company saying don't do it, and they did,
and so it's almost like the World Trade Organization cannot
work in isolation from these high income countries, and they
weren't getting support from high income countries either Germany, which
(27:59):
was the place of buy in tech, nor the United States,
which was the place of maderna um. What do you
think of the argument that if there are taxpaired dollars involved,
and there are private financings of drug development, that the
initial benefits, the initial harvesting of those gains should stay
(28:20):
within the country that financed it. I think that was
typically an argument that came out that the politicians and
private companies wanted to make sure their own citizens were
fully inoculated before any shipments went to other countries. You know,
what I would say about that is that that in
general could make sense to me if this wasn't a
(28:41):
highly transmissible respiratory virus where high rates of transmission occurring
in other countries with low rates of immunity will affect
us here in the United States. The Delta variant that
we do not know exactly where it emerged was first
identified in India. The omicron variant we don't know where
to emerge was first identified in South Africa. How interesting
(29:01):
that it was those two countries who were begging the
w t O for vaccines. And the reason that I
say that is we are all affected by global health.
That's the thing about a highly infectious pathogen. That it
mattered that India had a terrible delta variant surge because
it came here and we quickly also had a bad
(29:22):
delta variant surge in places who were under vaccinated. In
the United States, places with low rates of vaccine, we
had plenty of vaccines. It was just that some states
didn't have the uptake that we were hoping for by
the time Delta hit our shores in July and it
affected us. It affected our hospitals, and it may not
have if we had thought together as a global health community,
(29:42):
what happens there matters here in the United States. Viruses
don't carry passports or think about borders. Do they exactly
exactly we do different. Maybe we should think about what
you just said. For rhumat logic diseases, cancer diseases, things
that are not highly infectious and contagious. This was a
global health emerg and see I think what happened in
it was tragic in terms of global vaccine equity and
(30:04):
and pandemics remind us at least when it comes to
public health. But I think there's other areas in which
it's true too that we are authentically a global community
that we can't really turn our backs on one another's
can we yes right now? Good example, the JUG Show
on January five had a press conference where they look
like they wanted to declare this pandemic over because things
(30:25):
were going so much better in every country but China,
and because things are not going that well in China
right now. We are linked to China. We are absolutely
linked to everyone is and the global pandemic will not
be declared over. Intel China can get through what they're
getting through right now with lower rates of vaccination than
they likely should have had before they massively opened up MO.
(30:45):
Darn Is is interesting in that context because they made
a patent pledge and they said that in the early
stages of the pandemic that they essentially wouldn't enforce what
they believe to be their legal patent claims against MANU
actors in developing countries. If other local manufacturers decided to
use Mo Danna's technology to solve these viral problems in
(31:09):
their own country, Danna would essentially look the other way.
And that's a pretty unusual and generous, publicly spirited posture
to take, isn't it. Yes, the day that happened, there
was a lot of love towards Maderna. So you can
say something, but if you don't follow through, it's not
like scientists, you know, won't remember this in the next
(31:31):
pandemic and you want to really follow through on. To me,
it doesn't even totally feel like generosity in the sense
that I think in terms of profit, Madonna really made
a profit and will continue to make profit. I think
it was more something that was holding true to their
obligations that they got a lot of external funding and
(31:51):
we were in the middle of a global health emergency
and they should have played balmar. So did you not
take their patent pledget face value? Do you think it
was a way to a late criticism them or was
it a legitimate positive step forward? You know, I have
to say that everyone was writing around that time. I
wrote a piece and Time magazine in March when I
(32:12):
was watching what was going on in India that said
please step up both the governments of G nine to
work on the trips waiver and also Madonna advisor and
I wrote a couple of pieces in other places at
that time. So they were getting a lot of pressure
around that time because it became revealed that letter that
they had written to President Biden where they said, please
ignore what India and South Africa asked for. We don't
(32:34):
think that's good in terms of profit. That letter had
been you know, I don't know what happened, but it's
somehow gotten the public space. So people were looking to Maderna.
So when they said that, I think everyone was very happy.
But we're now what we're almost two years past that
point in March, and we don't have these you know,
sort of freely being made in other countries for distributions.
(32:56):
So the vaccines that we're getting in some of our
countries right now, China doesn't have massive production of MRNTI vaccine.
It has a vaccine, but it doesn't have the same vaccine.
And this vaccine works well, it really works well, you know,
in the same way that patents and the bottom line
get in the way of developing countries getting access to
drugs they need. Even in developed countries, the pricing sometimes
(33:19):
can be so exorbitant that certain drugs can be out
of reach of citizens, even in the countries in which
the drugs are developed. And pharma companies have often said,
our pricing is a reflection of the time it takes
to develop a drug and the massive investment we need
to make into that development. But they're also not very
transparent about actually sort of showing their costs and showing
(33:43):
their processes to substantiate that completely, are they yes. So,
for example, there was a statement made that these m
RTI vaccines really hard to make, but the ceremon Institute
in India had already claimed in October when they wrote
the w U TiO we don't think they're very hard,
and we really have the technology, we have the institute,
(34:04):
we have the factory, we can do it. And so
there's this statement made that they're so hard, but you
really need the recipe, you really need the patent to
look at so you can see if they can make it.
That was an excuse used for antirectoral therapy. But once
India started making natural therapy for the world. The trajectory
of the world changed in HIV oh by the way,
(34:24):
India violated the patent and they sort of the drug
companies look the other way. Why did they look the
other way in that case, because again the international pressure
was so loud at that point. Sub Saharan Africa is
really always been the epicenter of the HIV pandemic. This
very visible meeting had just happened that the International AIDS
(34:47):
conference in Durban, and it just would have looked so
bad for the pharmaceutical companies to sue South Africa for
buying these drugs from India, or to sue India to
making the drugs that they just complaining and uh and
these drugs they were part of the pep FAR program.
The pep FAR program the President's Emergency Plan for Age
Relief formed under President Bush and he and program going
(35:11):
forward really led to a mass dissemination event. Director of
out Therapy worldwide, but it was using the cheap drugs
made in India. So how do we resolve this collision
between innovation and avarice? Is it resolvable? Is it a
collision that ultimately has positive results? Is it one in
(35:31):
your mind that is always going to be a little
bit scarred. How do you think about that? I always
think of that whatever you do comes back to you.
I mean we say this in human beings, like if
we behave unselfishly, you know a lot of that kind
of rewards come back to you. I have no doubt
that companies in the middle of a global health emergency,
because there are high incominations, will always make profit. If
(35:54):
they make something innovative to combat that pandemic. I think
they will always make profit. But what will come back
to them is an incredible feeling of goodwill, of more
scientific input, of more money into their company, of more
interactions with the federal government if they behave more nobly
and with less average to try to help control the
(36:15):
epidemic and to provide global vaccine equity to these medications.
So good example the two antivirals moment, pair of Air
and pax Lovid, those companies of which one was Fighter
and one was Mark. Immediately when they made their antiviral products,
worked with the medicine's patent pool and said we're gonna
make these available in low income countries. We're gonna give
our formula out we're not even gonna do what Maderna
(36:37):
did on the public stage and make it look like
we're not going to give out the formula for these
to be made in low resource settings. And they did that,
and there was an incredible amount of goodwill towards them.
And then what does that do That makes the federal
government buy a lot of packs LOVID doses for the
US population. They made a lot of money. It's always
going to come back to them, I think, And so
try to behave well for the public. Shaming occurs, yes,
(37:02):
exactly exactly, but Viser came out looking good in terms
of paxilovin. So tell me, what have you learned from
watching Modanna and some of the other vaccine wizards during
the COVID crisis. You know, you're the smartie, I said
at the top of the show. I'm not a scientist.
You're the scientist. So probably there's less in all of
this that is a learning moment for you. But I
(37:22):
was really curious about anything that you might have learned
from all of us. I mean, one thing I have
learned is just to go back to something we said
at the beginning, I think this technology, whatever you think
about it, because of course there's been misinformation and there's
been some kind of back and forth about the safety
these vaccines. I actually think that these vaccines have been miraculous,
and the reason they've been so miraculous is they make
(37:44):
really high levels of proteins. So when I think about
older people, amy no compromised individuals like the patients I
take care of living with HIV, I want them to
have the MR and a vaccine because such high levels
of protein are made, such a vigorous immune responses made
that though we can't prevent all infection severe disease, there's
an incredible protection against severe disease. So this is not
a technology we should ever, you know, not use. I
(38:07):
think it's going to be used in in the future
if we have a new pathogen. So what I would
say is that don't give up in the emory technology,
don't give up in these companies. Maderna. Should I hope
start working better together with both the legacy of what
happened from the NIH. Now Dr Graham has actually retired.
He wanted to retire before, but he was in the
(38:28):
middle of a pandemic, so he has now retired. The
NIH should always be your friend if you are an
innovative drug company, so work well with the NH dropped
the patent against Fiser. These are vaccines that have been
again in existence for a while and it was not
like Fiser went to Maderna and stole anything. And that
will also look good if they drop that and express
(38:49):
some generosity. So express some degree of willingness in terms
of low resource countries being able to make these India
and South Africa, and then the next pandemic we're going
to turn to Maderna. Well, I could keep talking to
you for another hour. This was a great conversation. Thanks
for joining us today, Monica, Thank you so much. Really
great questions and conversation and really relevant for the future.
(39:09):
You can follow Dr Monica Gandhi on Twitter at Monica
Gandhi nine, and you can preorder her book Endemic, a
post Pandemic Playbook, which will be published this summer. Here
at crash Course, we believe the collisions can be messy, impressive, challenging,
surprising and always instructive. In today's Crash Course, I learned
(39:32):
that pharmaceutical companies can be innovative and great, and they
can also be good if they just put the bottom
line aside for a little while, sometimes, especially during a
public health emergency. What did you learn? We'd love to
hear from you. You can tweet at the Bloomberg Opinion,
handle at Opinion or me at Tim O'Brien using the
(39:53):
hashtag Bloomberg Crash Course. You can also subscribe to our
show wherever you're listening right now and leave us a review.
It helps more people find the show. This episode was
produced by the indispensable Anna Mazarakas and me. Our supervising
producer is Magnus Hendrickson, and we had editing help from
Katie Boys, Jeff Grocott, Mike Nitza, and Christine Vanden. By large.
(40:18):
Blake Maples does our sound engineering, and our original theme
song was composed by Luis Gara. I'm Tim O'Brien. We'll
be back next week with another Crash Course.
Welcome to Crash Course, a podcast about business, political, and
social disruption and what we can learn from it. I'm
Tim O'Brien. Today's crash Course COVID nineteen vaccines versus the
bottom Line. I am not a scientist. Repeat, I am
not a scientist, but I am a user of COVID
(00:22):
nineteen vaccines. I think they're miracles and the single biggest
reason the pandemic wasn't more devastating. But if that perspective
makes you erupt, please relax. I'm focusing today on the
companies that produced the vaccines, not the science. And I
have a question. Have those amazing innovators, those life savers
(00:42):
played fairly when it comes to sharing the financial spoils
of their miracle drugs, and they were miracles. Just about
nine months after the U S went into lockdown in March,
the first vaccine jabs were available. There are a handful
of marquee companies that won that race, Visor by Tech,
Johnson and Johnson and Astra Zeneca among them. But today,
(01:05):
for purposes of a lively discussion about innovation and avarice,
I want to focus on moderna. It will help keep
our conversation on point and MODERNA is a useful proxy
for examining how a groundbreaking vaccine was on earthed and
who got control of its uses. And to do that,
I've invited Dr Monica Gandhi, a leading virologist and epidemiologist
(01:27):
who also teaches at the University of California, San Francisco,
to join our podcast. Hi Monica, Hi, thank you. It's
great to see you and to talk to you. So,
first tell our listeners a little bit about yourself. How
did you end up devoting your career to battling some
of nature's most dangerous stalkers viruses? You know, Actually my
(01:51):
entire interest in viruses came about when I was quite young.
I was only twelve, but it was when the HIV
epidemic was first reported. I got fascinated by that. Yeah,
it was one June, to be exact, were the first
case reports of these devastating infections, and usually young men
(02:11):
who obsessed with men. It was out of the blue.
It felt horrible, And what struck me, even at that
young age, is that viruses or other bacteria or others,
fungi or others, parasites are others. There's us as humans,
and then there's pathogens. That attack us. And when you
say others, you mean like intruders exactly, intruders that come
(02:34):
from the outside and really have nothing to do with us.
And we have strategies, or at least have developed strategies
over the years of technologic advances to fight the other. Well,
go back on what the hook was for you. You said,
you know, you described them as outsiders or invaders. Do
you see yourself as sort of a detective Yeah, I
(02:57):
like that idea. I think scientists are detectives because is
by the way, we're going to be getting more viruses
and and the planet is changing, and but it is
sort of detective work. And then it's this idea of optimism.
And I think that's what appealed to me at the
age of only twelve, is that it's optimistic to think
that we have the technologic tools and we can develop
(03:19):
them if we work hard enough to fight all these
pathogens coming our way. And I was amazed by the
optimism of infectious disease. I really have to tell you
that if you meet any infectious disease doctor, they have
a sense of optimism. We're going to get this, we're
going to fight it, we're going to figure out how
to combat it, and that's what happened with so many viruses.
(03:39):
That's not a bad way to live. It's not a
bad way for you to live, a very positive way,
enjoying solving mysteries and feeling hopeful about the outcome. Helpful
exactly right. Well, so let's talk a little bit about Moderna.
It's a pretty spectacular company, right. Can you talk a
little bit about its history if you would, in the
development of m RNA vaccines, Yes, So, just to be clear,
(04:01):
MR and A vaccines by the way, it's not like
they're brand new. You know, a lot of people say, oh,
there was no such thing as mr anda vaccine technology. Actually,
remember we've had three major coronavirus is come out and
cause severe disease in the last twenty years. The first
one was the stars pandemic two thousand to two thousand three.
The second one was merrs. All these are coronaviruses, and
(04:25):
that was the time with mers that the mr and
A technology was pulled out. It was already an idea
developing that you take instead of part of a virus.
Because we all got dip theory of vaccine, tetanus vaccine
protusses vaccine, and you know what we got. We got
a piece of the protein of the virus put together
(04:46):
with something called it adjument, and that made us raise
an immune response. But the mr and A technology is
to give the recipe for that piece of protein, not
the protein itself, but the recipe book for you, the
human body, to make up the protein in higher levels
so that you raise really vigorous and importantly a strong
(05:06):
immune response. M RNA goes away, the protein goes away,
but you have that immune response to live with. And
so this was a technology that really started way before
this pandemic, in the mirrors pandemic, but we didn't need
it because Morse sort of dwindled out. I mean, we
sort of got lucky escaping stars and mirrors, right. We're
fortunate to a certain extent that stars and mirrors didn't
(05:28):
become what COVID nineteen became. Yes, I mean, it's really
an interesting question. I mean, they didn't spread in the
same degree before you had symptoms, so you knew, you know,
when you had stars, and then you could isolate those
individuals and then fundamentally, actually they did make people very
sick and very unfortunately, and so we could again isolate
(05:49):
and they just sort of dwindle. Both of them went
away without the need for vaccines. But COVID nineteen we
were never going to get away with that. And so
in the wake of Stars, this little company that calls
itself I think originally modified r n A and then
they shortened that into Moderna opens its doors up in Cambridge, Massachusetts.
(06:10):
Exactly not a new technology. This Maderna company started in
two thousand and ten. So you know, remember that, like
it wasn't that this is some brand new technology. We
wanted it to have a company that would be focused
for the next pandemic. As SARS went away in its own,
Where's went away on its own. The idea was, if
we ever had a pandemic, Maderna and other companies like
(06:33):
this would lie waiting with this novel technology. And Maderna
was doing cool things and has done cool things. How
was it looked upon or received within the both the
research community, the public health community, the greater kind of
commercial pharmaceutical community. What did people think of Moderna in
(06:53):
its early days? It was looked on very favorably because
it was this little company that could and it was
just really trying to work on, for example, cancer vaccines,
human metanuma virus, thinking about using this for influenza, for ours, fee,
for all these other viruses that we've been having, and
I don't have a vaccine yet. But to be honest,
it wasn't very well known. And then it was sort
(07:16):
of chugging along and chugging along, and then reality turned
it into a star in the broader idea of innovation
in the pharmaceutical world. I mean, how hard is it
to authentically innovate to really produce knockout revolutionary drugs. Actually,
this is a great question because in the history of vaccinology,
(07:40):
we have these kind of basic ideas, right, Like smallpox
was the first vaccine that was thought about. And what
they did, Edward Jenner, was take another virus that looked
like smallpox, vaccinia and also cow poxies are cousins of smallpox.
They're also cousins of monkey box by the way, and
put a little bit of that into humans. Put a
(08:02):
little bit of a related virus into humans. So that
was the first vaccine technology. And then when we went
around in time, it was like, wait, I don't want
to give you a live vaccine, you know, from even
a cousin. I don't want you to get that cousin.
So let's think about putting pieces of the virus, innocent
pieces of the virus, not the whole virus, Innocent pieces
of the virus linked together with an adjuvent. Or we'll
(08:24):
give you the whole virus, but we're gonna kill it,
We're gonna inactivate it, or we're gonna at least make
it very weak. And these were all the viral technologies
we had. The idea that mcderna, who started in two
thousand ten and was working on MR and A technology
two thou seventeen and then the knockout in two thousand
and twenty, the idea that we have this totally novel
vaccine technology for our next pandemic was amazing because the
(08:51):
vaccines that we have work well, but we needed a
vaccine that worked really well. This is a worldwide pandemic.
Then we should, I think, probably be grateful about the
level of high quality innovation that exists within the biotechnology
and the pharmaceutical community. Yeah, I totally agree. Yeah, And
and it's rare, it's really rare to get one of
(09:13):
these drugs that's like a Grand Slam, A lot of
money gets poured in, a lot of research gets poured in,
but there can be misfires, right, Yeah. And actually, to
be very fair on what you said, I should say
that I've been in academia all my life. I'm an
n H funded researcher, and i know the NH very well,
and I know universities very well. But really, for knockout
products like this, we do need to work with our
(09:35):
biotechnology and pharmaceutical industry colleagues. Really to make immunotherapy for cancer,
to make cancer vaccines, to make a Marni vaccines, we
need a company that has the innovation and also the
funding in it and the production capacity to make products
at scale. So this is a major link that we
(09:57):
have between academia and industry our novel rugs, and we
need them. And and there's a third link, isn't there
the federal government and the deep, deep pockets of Uncle Sam.
Because the trajectories of these drugs are so long, the
risk in whether they'll even come to market is so high,
and the cost is so exorbitant that when companies can
(10:20):
a partnership with the federal government is often very useful. Right, Yes,
And it's a great question that you asked, because it's
not just the n I H that would maybe say
fund a research innovation, but it's the f d A
that helps work with companies to say, really, if you're
going to produce this, we're going to help work with you,
and we're gonna get it out quickly. We're going to
(10:40):
approve it more quickly. And it's also was very unprecedented.
But Operation work Speed in this setting of sarce COVID
two was really the federal government saying, okay, look, we
have a novel virus. Life has you know, ground to
a stand still worldwide. We need to get out of
vaccine quickly, and we're gonna independent funding and invest in
(11:02):
a private public partnership. And that was innovative. We have
to give credit to Operation Warp Speed and Moderna was
a direct beneficiary of that that the head of Operation
Warp Speed had been on Moderna's board. MODERNA got I
think around ten billion dollars in federal funding to help
it do R and D around m R and A,
and I think it had a partnership with the federal
(11:22):
government that lasted for at least I think four years
prior to bringing their vaccine to market. How do you
see Moderna's role during the early stages of the pandemic
When you think about the importance of MODERNA as an
entity at that time, you know, I see Maderna as
extremely important at the in the early phases of the
(11:42):
pandemic because everyone was rushing to make a vaccine. But
there were sort of eyes on Maderna because in two
thousand and seventeen, Madderna had developed a prototype of an
mRNA vaccine four different viruses, including human metauma virus which
causes is a sort of a respiratory viral syndrome every
(12:03):
winter in people. And so there had been an immediate
look at this novel technology of Maderna. To be fair,
and I'm sure that people know this history, but the
Vaccine Research Center, like you said, the federal government had
already funded Maderna and been involved in Maderna. So Barney Graham,
as the lead scientist at the Vaccine Research Center at
the n I AGED had been involved in the mRNA technology,
(12:26):
really helped co develop it. So it wasn't just a
financial relationship, it was also a research and development relationship. Definitely,
definitely a scientific relationship because Berney Graham had already written
a paper just the year before in Nature magazine that said,
if we ever have a pandemic, we have to have
the vaccine as fast as possible using novel technologies, which
(12:48):
was obvious. I mean, he's reflecting what we're all thinking,
is that if we get a pandemic, unlike influenza, where
there was no vaccine, it went away because fortunately a
lot of people died of the virus, it went away
on its So was the first influenza vaccine ever developed.
So it didn't go away through technology. And so we
(13:10):
knew from nine that this time we couldn't let her
go away through natural immunity and through more mortality. We
needed to help quell the mortality through vaccine technology. Monica,
I want to ask you more about the partnership between
MODERNA and the government. Well, let's take a quick break
from a word from one of our sponsors, and we'll
(13:30):
jump into some of the patent battles when we return. Okay, So,
Dr Monica Gandhi and I were just talking about the
relationship between the federal government and pharmaceutical companies, and the
federal government and MODERNA specifically as being one of those
useful private public partnerships that helps bring things to market
(13:55):
more quickly and ideally with better outcomes. And Darren is
sort of the post your child for an outcome like that,
isn't it Monica? Yes, because close ties between the n
i H and Maderna R mad had developed a novel
technology with the help of the NH and the Vaccine
Research Center at the NH with Barney Graham, and it
was almost poised to be the company that brought us
(14:17):
the vaccine for COVID. Do you recall where you were
or how you heard about the idea that there was
going to be a popularly available vaccine that could not
COVID nineteen off of its heels. Oh, I remember very
rough because even though December eleven was the first u
(14:39):
A for the vaccine in the United States that was
through FISER, November nine was the first time that we
got the results from FISER and November sixteen was the
first day that we got the results from Maderna. This
is two thousand twenty. I was thrilled the results were profound,
just this incredible level of protection against automatic COVID with
(15:01):
both of these mr and A vaccine products. A lot
of talking to the press around that time, just I
was sort of really very excited and very thrilled. I
just couldn't believe it was so fast. November nine after
March eleven, that's less than nine months. It's amazing. Eight
months ago we got the results, nine months we got
the product to you. When people used to talk about
(15:22):
drug development taking years, right exactly, I just I couldn't
believe it. I felt like it was a day like
going back to my history and why I was so
interested in virology, where everything was full of hope, everything
turned around. It was that optimism and we got it.
That's all I cared about. Well, and you know, you
(15:42):
mentioned the influenza epidemic of a century before and how
they just basically waited it out and had to let
the bodies pile up because they lacked the science. They
lacked the innovation then to be able to combat it.
And that is a hallmark of progress in our era,
isn't it? Thinks Actually, I mean I have also because
I'm really interested in infectious disease. I've really read a
(16:04):
lot about a history of infectious disease. Prior to the
development of new technologies, we had to wait everything out,
and we waited it out through misery and through death
and suffering. And the same was true of HIV at
the beginning of the pandemic, before we got the novel
and treach of our therapies. It was terrible, but we
didn't have that technology. And I don't know about other industries.
(16:26):
I'm sure this people think the same thing and energy
and other things. But I knew that we can never
have another pandemic again where we didn't have technology waiting
in the woods to essentially control it. Otherwise the death
and suffering would have been much much more. We have
had almost seven million deaths from COVID nine team worldwide.
That is unacceptable, but it is so much less than
(16:47):
we would have had. You know, there was this very
spirited debate around a lot of the different drugs and
vaccines that came onto the market during the early days
of COVID, around whether or not they were fast fairly
and whether or not everyone had the access to those
drugs that needed them, And it sort of became this
(17:08):
interesting discussion about both innovation and I think miracles and
avarice and overreach and justice. Yeah, and I wonder if
you have any thoughts about how you think about that
around any of the big pharma companies or the small innovators. Well,
this is a great question because I'm really a student
(17:30):
of HIV history in the sense that I grew up
thinking about HIV a lot. And when you look at
the history of HIV, there were incredible innovations in HIV
which were really the anti viral therapeutics that were developed
and disseminated in the US and Europe. By in the meantime,
HIV was raging in Sub Saharan Africa and India and
(17:53):
Eastern Europe and other places that actually didn't have access
to these medications, and it became a global and very
visible fight and advocacy from the HV community, from scientists,
from clinicians, from researchers, from patients that said, wait, how
can we save the lives of only one group of
people when we have novel technology and not that saved
(18:15):
the lives of a whole other group of people because
they live in lower income nations. And the two thousand
International AIDS meeting, which is in Durban, South Africa, it
was just fiery and it was all protest. It was
people from the U S and Europe saying I'm not
taking these medications until my brothers in South Africa can
get these medications. It was very, very vocal and very visible.
(18:37):
We were horrified that the innovations would not be given
to low incombinations. Well, generally, how do the drug companies
respond to protests like this or criticism of them about
the availability and access to their drugs? So sometimes very
ignore the communities, and then sometimes they're very responsive. So
(18:58):
what happened is the year two thousand when the International
AIDS meeting was drowned out by the Dinner protest. Really
what happened is that Fiser at the time was making
a very cheap medication called flu connisol, which would combat
cryptococ commeningitist, which is a very high mortality opportunistic confection
in AIDS, and they made a billion dollars in the
(19:19):
year two thousand from flu connisole. And it just seemed
unconsciousable that we'd have this very cheap drug that should
be could be made by generic companies and marketed to
the rest of the planet, and Fiser was making that
much money. And they did respond, and there was a
process that occurred through the World Trade Organization, the w
(19:40):
t O called the trips waiver, and what the w
t O meant at the time is that if we're
in the middle of a massive global health emergency, patents
may not matter to the same degree as they would
and we may have to waive those patents through the
trips waiver to a allow companies in South Africa and
(20:02):
India and kind of middle resource nations to get the
formula and to make these medications more cheaply and to
give them out to low income resource nations. And that
really occurred as a result of HIV and equity. You
bring up patents, which is another sort of leg of
the stool and watching I think how pharmaceutical companies protect
(20:23):
their research, protect their products, but also protect their bottom line.
You know, there's a lot of patent battles that occur
in the pharmaceutical world. Patent trolling is a big thing
in big pharma. Talk a little bit about that. How
much of the patent battles are over really legitimate claims
to intellectual property, and how many of them are anti
(20:44):
competitive or are simply used to sort of protect something
that might have a more generic use. So to be fair,
the reason that patents came about, obviously is that the
company would say, you know, we need to make money
off of our products because put in a lot of
research and development into our product, and that comes money.
In this case, of course, the operation Workspeed had invested
(21:06):
ten billion dollars from the US federal government into the
Maderna vaccine. But under more normal circumstances where we're not
in the middle of a global health emergency, usually it
is the company itself that's come up with that money.
And the point of protecting patents is to say, we
need to spend some time and tell the medication naturally
becomes generic, because after a certain amount of time, every
(21:27):
medication is allowed to be made by generic manufacturers. The
companies would say, it's we need this patent to protect
our profit and I do understand that again under normal circumstances,
but these aren't normal circumstances. Well and moderna there's even
an extra little twist in all of it, because what
did it do after it engage in this sort of
(21:48):
mutually effective and profitable partnership with the federal government to
develop a vaccine, bring it to market, and start to
reap the financial gain of that, including a skyrocketing stock price.
It began to threaten the federal government with a lawsuit.
It said it was going to take the government to
(22:08):
court under the claim that it had soul rights to
the patents around its COVID nineteen vaccine right right. So
that was a very surprising day because not only had
the government invested from Operation Warp Speed into Maderna, and
not only had the government, through the Vaccine Research Center
at the NIH, helped contribute to the technology scientifically with
(22:30):
Dr Graham and his research associates, but finally the government
had actually agreed to give Maderna and Feiser the money
and pay for the COVID vaccines because we're in the
middle of a global health emergency and a US public
health emergency. So instead of people having to get this
through their insurance, we made this vaccine widely available in
(22:50):
pharmacies for everyone, whether they have insurance or not, undocumented immigrants,
doesn't matter. You can go and get it at a pharmacy.
But how can you go and get it a pharmacy
because a government purchased these vaccines from Maderna. So to me,
I was shocked because it seemed like Maderna had had
plenty of investment from the federal government and I mean
(23:11):
the whole idea of the intellectual property from Dr Graham
was ignored and they sued the federal government. And I
will just tell you as someone who's NIH funded, I
would be on calls and people at the n H
were very frustrated and shocked. Well, Moderna ultimately backed away
from those legal threats, but they, you know, they also
had interesting arguments. You know, when Moderna would be sued,
(23:33):
they would argue on occasion that the federal government had
to defend the lawsuit because it was the federal government's product.
But when it came to this patent battle, they wanted
to claim it as their own. Doesn't seem like they
can have it both ways though, there, you know, right,
And I think Moderna was also sued Visor and bion
Tech for patent infringement, and Moderna itself has been sued
(23:53):
by other competitors. It becomes this big tangle of patent
battles that can often obscure or you know, what people
want out of the drugs themselves and how to bring
them to market effectively. Yes, I think it makes the
company's look really greedy, like you said, because actually both
Madonna Adviser have made a lot of money during the pandemic,
(24:14):
and it makes them look like they're not responding to
equity concerns about how we give these vaccines to low
income countries, and it just it's not like we're not
going to use these products. But it did frankly leave
a lot of people in the scientific community called. Okay,
I think we should take one more break here and
um when we get back, I want to talk about
(24:35):
the effect that moderna has overreach has had bringing vaccines
to the rest of the world, and that will come
up after these ads. We're back with Dr Monica Gandhi, who,
by the way, you can pre order her new book, Endemic,
a post pandemic Playbook. It will be published this summer.
(24:56):
I will be an eager reader, as I'm sure many
other people will be. My Nica. We were talking just
before the break about these internet signed patent battles in
the US and Western Europe, primarily I guess some parts
of Asia over control of vaccines. But what are those
sort of battles ultimately mean for low income to moderate
(25:20):
income countries, primarily those in the southern hemisphere where they
lack the public health infrastructure and the private public partnerships
to deliver these kind of drugs to their own citizens.
What do these battles mean for them? So it means that,
you know, residents of those nations lose out, and it's
(25:41):
really unfair. So to just clearly lay this out. India
and South Africa had not really suffered from COVID that
much by October of because we still hadn't gotten into
the new variants essentially, but there was an anticipation that
we would have new variants. We'd already had one called
D six fourteen G and so they were smart enough
(26:02):
to say, well, just because we've been relatively spared so far,
it's not like we're not going to need these vaccines.
We see the writing on the wall. You're developing these vaccines,
and they wrote a letter. Indian South Africa wrote a
letter to the World Trade Organization in October saying something
bad could happen, we could get a new variant. It's
not like we're going to get through this without vaccines,
and please invoke the trips waiver to ask Maderna and
(26:26):
fiser or who are developing these vaccines. And we got
the data just a month later to waive the patent,
so that we can make these m RNI vaccines in
our nations, and why is it Indian South Africa because
they basically have the ability to make these vaccines. They're
kind of middle resource countries. They have already shown that
they can make gantredge of our therapies and other medications.
They had the technical capability. They said, please invoke the
(26:50):
trips waiver to the w t O so that we
can make the vaccines as soon as they're ready. W
T I said no, And in the meantime we had
an election and Maderna and Fiser wrote letter to President
Biden assumed as he was elected and said, you know
that letter from India and South Africa, that's a really
bad idea. Don't do it. And so unfortunately Biden for
a while did not actually support the trips waiver, and
(27:14):
we got well into some very bad times, specifically the
delta variant in India with a four percent vaccination rate
in March. And then why did the w t say no?
Because you really do need support from the world community.
It is the World Trade Organization and fundamentally it is
partially dependent on G nine nations and eventually, I hope,
(27:37):
would hope G twenty saying these high incombinations supporting the
trips waiver because obviously these nations are getting pushed back
from the company saying don't do it, and they did,
and so it's almost like the World Trade Organization cannot
work in isolation from these high income countries, and they
weren't getting support from high income countries either Germany, which
(27:59):
was the place of buy in tech, nor the United States,
which was the place of maderna um. What do you
think of the argument that if there are taxpaired dollars involved,
and there are private financings of drug development, that the
initial benefits, the initial harvesting of those gains should stay
(28:20):
within the country that financed it. I think that was
typically an argument that came out that the politicians and
private companies wanted to make sure their own citizens were
fully inoculated before any shipments went to other countries. You know,
what I would say about that is that that in
general could make sense to me if this wasn't a
(28:41):
highly transmissible respiratory virus where high rates of transmission occurring
in other countries with low rates of immunity will affect
us here in the United States. The Delta variant that
we do not know exactly where it emerged was first
identified in India. The omicron variant we don't know where
to emerge was first identified in South Africa. How interesting
(29:01):
that it was those two countries who were begging the
w t O for vaccines. And the reason that I
say that is we are all affected by global health.
That's the thing about a highly infectious pathogen. That it
mattered that India had a terrible delta variant surge because
it came here and we quickly also had a bad
(29:22):
delta variant surge in places who were under vaccinated. In
the United States, places with low rates of vaccine, we
had plenty of vaccines. It was just that some states
didn't have the uptake that we were hoping for by
the time Delta hit our shores in July and it
affected us. It affected our hospitals, and it may not
have if we had thought together as a global health community,
(29:42):
what happens there matters here in the United States. Viruses
don't carry passports or think about borders. Do they exactly
exactly we do different. Maybe we should think about what
you just said. For rhumat logic diseases, cancer diseases, things
that are not highly infectious and contagious. This was a
global health emerg and see I think what happened in
it was tragic in terms of global vaccine equity and
(30:04):
and pandemics remind us at least when it comes to
public health. But I think there's other areas in which
it's true too that we are authentically a global community
that we can't really turn our backs on one another's
can we yes right now? Good example, the JUG Show
on January five had a press conference where they look
like they wanted to declare this pandemic over because things
(30:25):
were going so much better in every country but China,
and because things are not going that well in China
right now. We are linked to China. We are absolutely
linked to everyone is and the global pandemic will not
be declared over. Intel China can get through what they're
getting through right now with lower rates of vaccination than
they likely should have had before they massively opened up MO.
(30:45):
Darn Is is interesting in that context because they made
a patent pledge and they said that in the early
stages of the pandemic that they essentially wouldn't enforce what
they believe to be their legal patent claims against MANU
actors in developing countries. If other local manufacturers decided to
use Mo Danna's technology to solve these viral problems in
(31:09):
their own country, Danna would essentially look the other way.
And that's a pretty unusual and generous, publicly spirited posture
to take, isn't it. Yes, the day that happened, there
was a lot of love towards Maderna. So you can
say something, but if you don't follow through, it's not
like scientists, you know, won't remember this in the next
(31:31):
pandemic and you want to really follow through on. To me,
it doesn't even totally feel like generosity in the sense
that I think in terms of profit, Madonna really made
a profit and will continue to make profit. I think
it was more something that was holding true to their
obligations that they got a lot of external funding and
(31:51):
we were in the middle of a global health emergency
and they should have played balmar. So did you not
take their patent pledget face value? Do you think it
was a way to a late criticism them or was
it a legitimate positive step forward? You know, I have
to say that everyone was writing around that time. I
wrote a piece and Time magazine in March when I
(32:12):
was watching what was going on in India that said
please step up both the governments of G nine to
work on the trips waiver and also Madonna advisor and
I wrote a couple of pieces in other places at
that time. So they were getting a lot of pressure
around that time because it became revealed that letter that
they had written to President Biden where they said, please
ignore what India and South Africa asked for. We don't
(32:34):
think that's good in terms of profit. That letter had
been you know, I don't know what happened, but it's
somehow gotten the public space. So people were looking to Maderna.
So when they said that, I think everyone was very happy.
But we're now what we're almost two years past that
point in March, and we don't have these you know,
sort of freely being made in other countries for distributions.
(32:56):
So the vaccines that we're getting in some of our
countries right now, China doesn't have massive production of MRNTI vaccine.
It has a vaccine, but it doesn't have the same vaccine.
And this vaccine works well, it really works well, you know,
in the same way that patents and the bottom line
get in the way of developing countries getting access to
drugs they need. Even in developed countries, the pricing sometimes
(33:19):
can be so exorbitant that certain drugs can be out
of reach of citizens, even in the countries in which
the drugs are developed. And pharma companies have often said,
our pricing is a reflection of the time it takes
to develop a drug and the massive investment we need
to make into that development. But they're also not very
transparent about actually sort of showing their costs and showing
(33:43):
their processes to substantiate that completely, are they yes. So,
for example, there was a statement made that these m
RTI vaccines really hard to make, but the ceremon Institute
in India had already claimed in October when they wrote
the w U TiO we don't think they're very hard,
and we really have the technology, we have the institute,
(34:04):
we have the factory, we can do it. And so
there's this statement made that they're so hard, but you
really need the recipe, you really need the patent to
look at so you can see if they can make it.
That was an excuse used for antirectoral therapy. But once
India started making natural therapy for the world. The trajectory
of the world changed in HIV oh by the way,
(34:24):
India violated the patent and they sort of the drug
companies look the other way. Why did they look the
other way in that case, because again the international pressure
was so loud at that point. Sub Saharan Africa is
really always been the epicenter of the HIV pandemic. This
very visible meeting had just happened that the International AIDS
(34:47):
conference in Durban, and it just would have looked so
bad for the pharmaceutical companies to sue South Africa for
buying these drugs from India, or to sue India to
making the drugs that they just complaining and uh and
these drugs they were part of the pep FAR program.
The pep FAR program the President's Emergency Plan for Age
Relief formed under President Bush and he and program going
(35:11):
forward really led to a mass dissemination event. Director of
out Therapy worldwide, but it was using the cheap drugs
made in India. So how do we resolve this collision
between innovation and avarice? Is it resolvable? Is it a
collision that ultimately has positive results? Is it one in
(35:31):
your mind that is always going to be a little
bit scarred. How do you think about that? I always
think of that whatever you do comes back to you.
I mean we say this in human beings, like if
we behave unselfishly, you know a lot of that kind
of rewards come back to you. I have no doubt
that companies in the middle of a global health emergency,
because there are high incominations, will always make profit. If
(35:54):
they make something innovative to combat that pandemic. I think
they will always make profit. But what will come back
to them is an incredible feeling of goodwill, of more
scientific input, of more money into their company, of more
interactions with the federal government if they behave more nobly
and with less average to try to help control the
(36:15):
epidemic and to provide global vaccine equity to these medications.
So good example the two antivirals moment, pair of Air
and pax Lovid, those companies of which one was Fighter
and one was Mark. Immediately when they made their antiviral products,
worked with the medicine's patent pool and said we're gonna
make these available in low income countries. We're gonna give
our formula out we're not even gonna do what Maderna
(36:37):
did on the public stage and make it look like
we're not going to give out the formula for these
to be made in low resource settings. And they did that,
and there was an incredible amount of goodwill towards them.
And then what does that do That makes the federal
government buy a lot of packs LOVID doses for the
US population. They made a lot of money. It's always
going to come back to them, I think, And so
try to behave well for the public. Shaming occurs, yes,
(37:02):
exactly exactly, but Viser came out looking good in terms
of paxilovin. So tell me, what have you learned from
watching Modanna and some of the other vaccine wizards during
the COVID crisis. You know, you're the smartie, I said
at the top of the show. I'm not a scientist.
You're the scientist. So probably there's less in all of
this that is a learning moment for you. But I
(37:22):
was really curious about anything that you might have learned
from all of us. I mean, one thing I have
learned is just to go back to something we said
at the beginning, I think this technology, whatever you think
about it, because of course there's been misinformation and there's
been some kind of back and forth about the safety
these vaccines. I actually think that these vaccines have been miraculous,
and the reason they've been so miraculous is they make
(37:44):
really high levels of proteins. So when I think about
older people, amy no compromised individuals like the patients I
take care of living with HIV, I want them to
have the MR and a vaccine because such high levels
of protein are made, such a vigorous immune responses made
that though we can't prevent all infection severe disease, there's
an incredible protection against severe disease. So this is not
a technology we should ever, you know, not use. I
(38:07):
think it's going to be used in in the future
if we have a new pathogen. So what I would
say is that don't give up in the emory technology,
don't give up in these companies. Maderna. Should I hope
start working better together with both the legacy of what
happened from the NIH. Now Dr Graham has actually retired.
He wanted to retire before, but he was in the
(38:28):
middle of a pandemic, so he has now retired. The
NIH should always be your friend if you are an
innovative drug company, so work well with the NH dropped
the patent against Fiser. These are vaccines that have been
again in existence for a while and it was not
like Fiser went to Maderna and stole anything. And that
will also look good if they drop that and express
(38:49):
some generosity. So express some degree of willingness in terms
of low resource countries being able to make these India
and South Africa, and then the next pandemic we're going
to turn to Maderna. Well, I could keep talking to
you for another hour. This was a great conversation. Thanks
for joining us today, Monica, Thank you so much. Really
great questions and conversation and really relevant for the future.
(39:09):
You can follow Dr Monica Gandhi on Twitter at Monica
Gandhi nine, and you can preorder her book Endemic, a
post Pandemic Playbook, which will be published this summer. Here
at crash Course, we believe the collisions can be messy, impressive, challenging,
surprising and always instructive. In today's Crash Course, I learned
(39:32):
that pharmaceutical companies can be innovative and great, and they
can also be good if they just put the bottom
line aside for a little while, sometimes, especially during a
public health emergency. What did you learn? We'd love to
hear from you. You can tweet at the Bloomberg Opinion,
handle at Opinion or me at Tim O'Brien using the
(39:53):
hashtag Bloomberg Crash Course. You can also subscribe to our
show wherever you're listening right now and leave us a review.
It helps more people find the show. This episode was
produced by the indispensable Anna Mazarakas and me. Our supervising
producer is Magnus Hendrickson, and we had editing help from
Katie Boys, Jeff Grocott, Mike Nitza, and Christine Vanden. By large.
(40:18):
Blake Maples does our sound engineering, and our original theme
song was composed by Luis Gara. I'm Tim O'Brien. We'll
be back next week with another Crash Course.
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