Kind: captions
Language: en
the jury found pfizer guilty of fraud
and racketeering violations how does big
farm affect your mind everyone's allowed
their own opinion
i don't think everyone's allowed their
own scientific facts despiser played by
the rules pfizer isn't battling the fda
pfizer has joined the fda
the following is a conversation with
john abramson faculty at harvard medical
school a family physician for over two
decades and author of the new book
sickening about how big pharma broke
american healthcare and how we can fix
it
this conversation with john abramson is
a critical exploration of the
pharmaceutical industry
i wanted to talk to john in order to
provide a countervailing perspective to
the one expressed in my podcast episode
with the ceo of pfizer albert berla
and here please allow me to say a few
additional words about this episode with
the pfizer ceo
and in general about why i do these
conversations and how i approach them if
this is not interesting to you please
skip ahead
what do i hope to do with this podcast
i want to understand human nature
the best and the worst of it
i want to understand how power money and
fame changes people
i want to understand why atrocities are
committed by crowds that believe they're
doing good
all this ultimately because i want to
understand how we can build a better
world together
to find hope for the future
and to rediscover each time
through the exploration of ideas
just how beautiful this life is
this our human civilization in all of
its full complexity the forces of good
and evil of war and peace of hate and
love
i don't think i can do this with a heart
and mind that is not open fragile and
willing to empathize with all human
beings
even those in the darkest corners of our
world
to attack is easy
to understand is hard
and i choose the hard path
i have learned over the past few months
that this path involves me getting more
and more attacked from all sides
i will get attacked when i host people
like jay bhattacharya or francis collins
jamie mertzel or vincent ruckanyello
when i stand for my friend joe rogan
when i host tech leaders like mark
zuckerberg elon musk and others when i
eventually talk to vladimir putin barack
obama and other figures that have turned
the tides of history
i have and i will get called stupid
naive
weak
and i will take these words with respect
humility and love
and i will get better
i will listen think learn and improve
one thing i can promise
is there's no amount of money or fame
they can buy my opinion or make me go
against my principles
there's no amount of pressure that can
break my integrity
there's nothing in this world i need
that i don't already have
life itself is the fundamental gift
everything else is just a bonus
that is freedom
that is happiness
if i die today
i will die a happy man
now
a few comments about my approach and
lessons learned from the albert berla
conversation
the goal was to reveal as much as i
could about the human being before me
and to give him the opportunity to
contemplate in long-form the
complexities of his role including
the tension between making money and
helping people
the corruption that so often permeates
human institutions the crafting of
narratives through advertisements and so
on
i only had one hour and so this wasn't
the time to address these issues deeply
but to show if albert struggled with
them in the privacy of his own mind
and if he would let down the veil of
political speak for a time to let me
connect with a man who decades ago chose
to become a veterinarian
who wanted to help lessen the amount of
suffering in the world
i had no pressure placed on me there
were no rules the questions i was asking
were all mine and not seen by pfizer
folks i had no care whether i ever
talked to another ceo again
none of this was part of the calculation
in my limited brain computer
i didn't want to grill him the way
politicians grill ceos in congress
i thought that this approach is easy
self-serving dehumanizing and it reveals
nothing i wanted to reveal the genuine
intellectual struggle vision and
motivation of a human being and if that
fails i trusted the listener to draw
their own conclusion and insights from
the result whether it's the words spoken
or the words left unspoken or simply the
silence
and that's just it i fundamentally trust
the intelligence of the listener
you
in fact if i criticize the person too
hard or celebrate the person too much i
feel i fail to give the listener a
picture of the human being that is
uncontaminated by my opinion or the
opinion of the crowd
i trust that you have the fortitude and
the courage to use your own mind to
empathize and to think
two practical lessons i took away first
i will more strongly push for longer
conversations of three four or more
hours versus just one hour 60 minutes is
too short for the guests to relax and to
think slowly and deeply and for me to
ask many follow-up questions or follow
interesting tangents
ultimately i think it's in the interest
of everyone including the guests that we
talk in true long form for many hours
second these conversations with leaders
can be aided by further conversations
with people who wrote books about those
leaders or their industries those that
can steal man each perspective and
attempt to give an objective analysis
i think of teddy roosevelt's speech
about the man in the arena i want to
talk to both the men and women in the
arena
and the critics and the supporters in
the stands
for the former i lean toward wanting to
understand one human being's
struggle with the ideas
for the latter i lean towards
understanding the ideas themselves
that's why i wanted to have this
conversation with john abramson who is
an outspoken critic of the
pharmaceutical industry i hope it helps
add context and depth to the
conversation i had with the pfizer ceo
in the end i may do worse than i could
have or should have
always i will listen to the criticisms
without ego and i promise i will work
hard to improve
but let me say finally
that cynicism is easy
optimism
true optimism is hard
it is the belief that we can
and we will
build a better world and that we can
only do it together
this is the fight worth fighting
so here we go
once more into the breach dear friends
i love you all
this is a lex friedman podcast to
support it please check out our sponsors
in the description and now here's my
conversation with john
abramson
your faculty at harvard medical school
your family physician for over two
decades rated one of the best family
physicians in massachusetts you wrote
the book overdosed america and the new
book coming out now called sickening
about how big pharma broke american
healthcare including science and
research and how we can fix it
first question what is the biggest
problem with big pharma that if fixed
would be the most impactful so if you
can snap your fingers and fix one thing
what would be the most impactful you
think the biggest problem is the way
they
determine the content
the accuracy and the completeness
of what doctors believe to be the full
range of knowledge that they need to
best take care of their patients
so that
with
the knowledge having been taken over by
the commercial interests primarily the
pharmaceutical industry
the purpose of that knowledge is to
maximize the profits that get returned
to investors and shareholders
and not to optimize the health of the
american people
so rebalancing that equation would be
the
most important thing to do
to get our health care
back aimed in the right direction okay
so there's a tension
between helping people and making money
so if we look
at particularly the task of helping
people in medicine
in health care
is it possible if money is the primary
sort of
mechanism by which you achieve that as a
motivator is it possible to get that
right i think it is lex but i think it
is not possible without guard rails that
maintain the integrity and the balance
of the knowledge without those guard
rails it's like trying to play a
professional basketball game without
referees and having players call their
own fouls but the players are paid to
win
and you can't count on them to call
their own fouls so we have referees who
are in charge we don't have those
referees in american health care that's
the biggest
um
way that american health care is
distinguished from health care and other
wealthy nations
so okay so you mentioned milton friedman
and you mentioned his book called
capitalism and freedom he writes that
there are only three legitimate
functions of government to preserve law
and order to enforce private contracts
and to ensure
that private markets work
you said that uh that was a radical idea
at the time but we're failing on all
three how are we failing and and uh also
maybe the bigger picture is what are the
strengths and weaknesses of capitalism
when it comes to medicine and healthcare
can we separate those out because those
are two huge questions
so
how we're failing in all three and these
are the
minimal functions
that our guru of free market capitalism
said the government should perform so
this is the absolute baseline
on preserving law and order
the drug companies routinely violate the
law in terms of their marketing
and uh
in terms of
their
presentation of the results of their
trials
i know this because i was an expert in
litigation for about 10 years
i
presented some of what i learned in
civil
litigation to the fbi and the department
of justice
and that case led to the biggest
criminal fine
in u.s history as of 2009
and i testified in a
federal trial in
2010 and the jury found pfizer guilty of
fraud and racketeering violations
in terms of
violating the law it's a routine
occurrence the drug companies have paid
38 billion dollars worth of fines from i
think 1991 to 2017.
it's never been enough to stop the uh
misrepresentation of their data
and rarely are the fines greater than
the profits that were made
uh
see uh executives have not gone to jail
for misrepresenting data
that have involved even tens of
thousands of deaths in the case of vioxx
oxycontin as well
and when companies plead guilty to
felonies which is not an unusual
occurrence
the government usually allows the
companies the parent companies to allow
subsidiaries to take the plea
so that they are not one step closer to
getting disbarred from medicare not
being able to participate in medicare
um
so in that sense
there is
a mechanism
that is appearing to
impose law and order on drug company
behavior but it's clearly not enough
it's not working can you actually speak
to
human nature here
are people corrupt
are people malevolent
are people ignorant
that work at the low level and at the
high level
advisor for example at big pharma
companies
how's this possible
so i believe
just in a small tangent that most people
are good
and i actually believe if you join
big pharma so a company like pfizer
your life trajectory often involves
dreaming and
wanting and enjoying helping people
yes
and so
and then we look at the outcomes
that you're describing
and uh it looks and that's why the
narrative takes hold
that like pfizer ceo albert brola who i
talked to
is
malevolent the sense is like
these these companies are evil so if the
the different parts
the people
are good and they want to do good how
are we getting these outcomes yeah i
think it has to do
with
the cultural milieu
that this is unfolding in
and
we need to look at sociology uh to
understand this that when the cultural
milieu
is
set up
to maximize the returns on investment
for shareholders and other venture
capitalists and hedge funds and so forth
when that
defines the culture
and the higher up you are in the
corporation the more you're in on the
game of uh
getting rewarded for maximizing the
profits of the investors
that's the culture they live in
and it becomes normative behavior
to do
things with science
that look
normal in that environment and our
shared values within that environment by
good people whose
self-evaluation becomes modified by the
goals that are shared by the people
around them
and within that
millior
you have one set of standards and then
the rest of
good american people have the
expectation that the drug companies are
trying to make money but that they're
playing by rules
that aren't part of the insider milieu
that's fascinating the the game
they're playing modifies the culture
you know of inside the meetings inside
the rooms day to day
that there's a bubble that forms like
we're all in bubbles of different sizes
right and that bubble allows you to
drift
in terms of what you see as
ethical and unethical
because you see the game as just you
know it's just part of the game
so marketing is just part of the game
right and paying the fines is just part
of the game
of science yeah
and without guard rails
it
becomes even more part of the game you
keep moving in that direction if you're
not
bumping up against guardrails
and i think that's how we've gotten to
the extreme situation we're in now
so like i mentioned i spoke with pfizer
ceo albert berla and i'd like to
raise with you some of the concerns i
raised with him
so one you already mentioned
i raised the concern that pfizer is
engaged in aggressive advertising
campaigns
as you can imagine he said no
what do you
think
i think you're both right
i think that the i agree with you that
the aggressive advertising campaigns
do not add value to society
and i agree with him that they're
for the most part legal
and it's the way the game is played
right so sorry to interrupt but
oftentimes his responses are
um
especially now he's been ceo for only
like two years three years
he says pfizer was a different company
we've made mistakes
right in the past we don't make mistakes
anymore
that there's rules
and we play by the rules so like uh with
every concern raised there's very very
strict rules as he says in fact he says
sometimes way too strict and we play by
them
and so in that sense advertisement it
doesn't seem like it's too aggressive
because it's playing by the rules
and relative to the other again it's the
game relative to the other companies
it's actually not that aggressive
but relative to the other big pharma
company yes yes i i hope we can quickly
get back to whether or not they're
playing by the rules but in general but
let's just look at the question of
advertising specifically i think that's
a good example of what it looks like
from within that culture and from
outside that culture
he's saying that we follow the law
on our advertising we state the side
effects and we state the fda approved
indications and we we do what the law
says we have to do for advertising and i
have not
i've not been an expert in litigation
for a few years and i don't know what's
going on currently but let's take him at
his word
it could be true it might not be but it
could be but
if that's true
in his world in his culture that's
ethical business behavior
from
a common sense person's point of view
a drug company paying highly skilled
media folks
to take the information about the drug
and create the illusion uh the emotional
impact and the take away message for
viewers of advertisements that grossly
exaggerate the benefit of the drug and
minimize the harms it's sociopathic
behavior
to have viewers of ads
leave the ad
with an unrealistic impression of
the benefits and harms of the drug
and yet he's playing by the rules he's
doing his job as ceo to maximize the
effect of his advertising
and if he doesn't do it this is a key
point if he doesn't do it he'll get
fired and the next guy will
so the people that survived the company
the people that get uh
raises in the company move up and the
company are the ones that play by the
rules and that's how the game solidifies
itself but the game is within the
balance of the law sometimes most of the
time not always
we'll return to that question
i'm actually more concerned
about the effect of advertisement
in a kind of
much larger scale
on the
people that are getting funded by the
advertisement
in self-censorship just like more subtle
more
uh more passive
pressure to not say anything negative
because i've seen this
and i've been saddened by it
that uh people sacrifice integrity in
small ways
when they're being funded by a
particular company
they don't they don't see themselves as
doing so
but you could just clearly see that the
space of opinions that they're willing
to engage in
or a space of ideas they're willing to
play with
is one that doesn't
include negative
anything that could possibly be negative
about the company they just choose not
to because you know why and that that's
really sad to me that
you know if you give me a hundred bucks
i'm less likely to say something
negative about you
um
that makes me sad because like the
reason i wouldn't say something negative
about you i prefer is the pressure of
friendship and human connection those
kinds of things
so i understand that
um that's also a problem by the way so
they started having dinners and shaking
hands and oh aren't we friends but the
fact that money has that effect is
really sad to me
on the news media on the journalists on
scientists
that's scary to me um but of course the
direct advertisement to consumers like
you said is a potentially very negative
effect i i wanted to ask if um
what do you think is the most negative
impact of advertisement is it that
direct to consumer on television
is it advertisement of the doctors which
i'm surprised to learn i was vaguely
looking at is more than the
advertisement
more spent on advertising to doctors
than to consumers that's really
confusing to me it's fascinating
actually and then also obviously the the
law side of things is the lobbying
dollars
which i think is less than all of those
but anyway it's in the ballpark what
concerns you most well it's the whole
nexus of influence
there's not one thing and and they don't
uh
invest all their they don't put all
their eggs in one basket it's a whole
surround sound um
program here yeah uh but
in terms of advertisements let's take an
advertisement trulicity is a diabetes
drug a tub for type 2 diabetes an
injectable drug
and it lowers blood sugar just about as
well as um
metformin does metformin costs about
four dollars a month
uh true licity costs i think sixty two
hundred dollars a year so
forty eight dollars a year versus sixty
two hundred trulicity has distinguished
itself because it did uh the
manufacturer did a study that showed
that it significantly reduces the risk
of cardiovascular disease in diabetics
and they got approval
on the basis of that study that very
large study being statistically
significant
what the so the ad the ads obviously
extol the virtues of trulicity because
it reduces the risk of heart disease and
uh stroke and that's one of the major
morbidities
risks of type 2 diabetes what the ad
doesn't say is that you have to treat
323 people
to prevent one non-fatal event at a cost
of 2.7 million dollars
and even more importantly than that what
the ad doesn't say
is that the evidence shows that engaging
in an active
healthy lifestyle program
reduces the risk of heart disease and
strokes far more than true licity does
now this to be fair to the company the
sponsor
there's never been a study that uh
compared trulicity to lifestyle changes
but that's part of the problem of our
advertising you would think in a
rational society that was way out on a
limb
as a a lone country besides new zealand
that allows direct to consumer
advertising
that part of
allowing direct-to-consumer advertising
would be to mandate that the companies
establish whether their drug is better
than say healthy lifestyle adoption
to prevent the problems that they claim
to be preventing but we don't require
that so
the companies can afford to do very
large studies so that very small
differences become statistically
significant
and their studies are asking the
question how can we sell more drug
they're not asking the question how can
we prevent cardiovascular disease in
people with type 2 diabetes
and that's how we get off in this we're
now on the in the extreme arm
of this
distortion of our medical knowledge of
studying how to sell more drugs than how
to make people more healthy
that's a really great thing to compare
to
is lifestyle changes
because that should be the bar if you uh
if you do some basic diet exercise all
those kinds of things
how does this drug compare to that right
right and that study was done actually
in the 90s it's called the diabetes
prevention program it was federally
funded uh by the nih so that there
wasn't this drug company
imperative to just try to prove your
drug was better than nothing
and it was it was a very well designed
study randomized controlled trial
in people who were at high risk of
diabetes so-called pre-diabetics
and they were randomized to three
different three different groups a
placebo group
a group that got treated with metformin
um and a group that got treated with
intensive lifestyle counseling
so this study really tested
whether you can get people in a
randomized controlled trial
assigned to
uh intensive lifestyle changes whether
that works
now the
the uh common wisdom amongst physicians
and i think in general is that you can't
get people to change you know you can do
whatever you want you can stand on your
head you can beg and plead people won't
change so give it up and let's just move
on with the drugs and not waste any time
except this study that was published in
the new england journal i think in 2002
shows that's wrong that the people who
were the in the intensive lifestyle
group ended up losing 10 pounds
exercising five times a week maintaining
it
and reduced the risk of getting diabetes
by 58
compared to the metformin group which
reduced its risk of getting diabetes by
so that
that exact study was done and it showed
that lifestyle intervention is the
winner
who
as a small tangent
is the leader
who is supposed to fight for the side of
lifestyle changes
where's the big
pharma version of lifestyle changes
who's supposed to have the big bully
pulpit the big money behind lifestyle
changes right in your sense because
because that seems to be missing in a
lot of our discussions about health
policy right that's exactly right and
the answer is
that
we assume that the market has to solve
all these problems
and the market can't solve all these
problems there needs to be
some way of protecting the public
interest for things that aren't
financially driven
so that the overriding question has to
be how best to improve americans health
not
companies funding studies
to try and prove that their new
inexpensive drug is better
and should be used well some of that is
also
people sort of uh like yourself i mean
it's funny
you spoke with joe rogan he constantly
espouses lifestyle changes so some of it
is almost like
understanding the problems that big
farmers creating society and then
uh
sort of these influential voices
speaking up against it so whether
they're scientists or just regular
communicators
yeah i think
you got to tip your hat to joe for
getting that message out
and he clearly believes it and does his
best
but it's not coming out in the
legitimate avenues in the legitimate
channels
that are
evidence-based medicine and the from the
sources that the docs are trained to
uh listen to and and modify their
patient care on now it's not a hundred
percent i mean there are articles in in
uh
in the big journals about the benefits
of lifestyle but they don't carry the
same gravitas
as the randomized controlled trials that
test this drug against placebo or this
drug against another drug so the joe
rogans of the world keep going you know
i tip my hat but it's not going to carry
the day for most of the people
until it has the legitimacy of the
medical establishment yeah like
something that the doctors really pay
attention to well there's there's an
entire mechanism established for testing
drugs
there's not an
entire mechanism established for in
terms of scientific rigor of testing
lifestyle changes i mean it's it's it's
more difficult
i mean everything is difficult in
science
with that science that involves humans
especially uh but it's just it's these
studies are very expensive
they're difficult it's difficult to find
conclusions and to control all the
variables and so it's very easy to
dismiss them unless you really do a huge
study that's very well funded and so
maybe the doctors just lean towards the
simpler studies
over and over which is what the drug
companies fund
they can control more variables
see but the control there is sometimes
by hiding things too
right
so sometimes you can just
say that this is a well-controlled study
by pretending there's a bunch of other
stuff just ignoring the stuff
um that could be correlated it could be
the real cause of the effects you're
seeing all that kind of stuff
so uh money can buy ignorance i suppose
in science it buys
kind of blinders that are on that don't
look outside the reductionist model and
and that's another issue is that we kind
of nobody says to uh doctors in training
only listen to reductionist
um
uh studies and conclusions and methods
of promoting health nobody nobody says
that explicitly but the
respectable science
has to do with controlling the factors
and um i mean it just doesn't make sense
to me
i'm going to pick on true literacy
because it's such an obvious example but
it's not more egregious than the than
many others
it doesn't make sense to me to allow a
drug to be advertised as preventing
cardiovascular disease when you haven't
included lifestyle changes as an arm in
the study it just
it's just so crystal clear that the
purpose of that study is to sell
trulicity it's not to prevent
cardiovascular disease you know
if if we were in charge i would try to
convince you that anywhere that study
the results of that study were
presented to physicians it would be
stamped in big red letters this study
did not compare trulicity to lifestyle
changes
they need to know that and the docs are
kind of trained these blinders get put
on and they're trained to kind of forget
that that's not there
do you think
so first of all that's a small or big
change to advertisement that seems
obvious to say
like in in enforce that it should be
compared to lifestyle changes
do you think advertisements period in
united states for pharmaceutical drugs
should be banned
i think they can't be banned so it
doesn't matter what i think
okay
let's say you were a dictator and two
why can't they be banned okay
uh either answer either one
i believe i've been told by lawyers who
i trust
that the uh freedom of speech in the in
the u.s constitution
is such that you can't ban them that
you could ban cigarettes and alcohol
which have no therapeutic use
but drugs have a therapeutic use and
they
uh advertisements about them can't be
banned let's assume that they can't be
because we know they won't be anyway
um but let's assume they can't be that
the and especially our supreme court now
is unlike would be unlikely to um take
that seriously
but that's not the issue the issue is
that if drugs want us if the drug
companies want to spend their money
advertising
they should have to
have independent analysis of the message
that the viewers are left with about the
drug so that it's realistic what's the
chance the drug will help them well with
intrulicity it's one out of 323. 322
people aren't going to benefit from the
cardiovascular reduction risk reduction
um
what's the true cost when when drugs
advertise that you may be able to get
this for a 25 copay or something
tens of thousands of dollars a year drug
for 25 copay what an enormous disservice
that is to misrepresent the costs of
society that should not be allowed so
you should have to
make it clear to the viewers how many
people are going to benefit what's your
chance of benefiting how does it compare
to lifestyle changes or less expensive
therapies what do you give up if you use
a less expensive therapy or gain perhaps
and how much it costs how much it costs
now that can go either way because if
you say humira cost 72 000
and it's no more effective as a
first-line drug than methotrexate which
costs 480
people might say i want the expensive
drug
because i can get it for 25 copay um so
you'd have to uh
temper that a little bit oh you mean
people are so
they don't care they don't care their
insurance is going to cover it and
it's a 25 copay but we could figure out
how to deal with that the the main point
is that
if we assume that advertisements are
going to keep going and they are
um
we could
require
that there be outside evaluation of the
message that reasonable unbiased viewers
take away from the ads
and the ads would have to tell the truth
about the drug
and the the truth should have like sub
truth guard rails meaning like the cost
that we talked about
the effects compared to things that
actually you know lifestyle changes
um
just these details very strict
guardrails of what actually has to be
specified
and i would make it against the law
to have family picnics or dogs catching
frisbees in the ads
so you mean 95 of the ads yes
um i mean there's something dark and
authentic about those advertisements but
they see i mean i'm sure they're being
done because they work for the target
audience
and then the doctors too
can you really buy a doctor's opinion
why does it have such an effect on
doctors
advertisement to doctors like you as a
physician again like from everything
i've seen people love you
and i of uh just
um people should uh definitely look you
up from
there's a bunch of videos of you giving
talks on youtube and it's just
just the it's so refreshing to hear just
a clarity of thought about health policy
about health care
just the way you think throughout the
years thank you
so like it's easy to think about like
maybe you're criticizing big pharma
that's part of one part of the message
that you're talking about but
you know that's not like
your brilliance actually shines in in
the positive in the solutions and how to
do it so
as a doctor
what affects your mind yeah and how does
big pharma affect your mind
number one
the information that comes through
legitimate sources
that doctors have been taught to rely on
evidence-based medicine the articles in
peer-reviewed journals
the guidelines that are issued now those
are problematic
because
when an article is peer-reviewed and
published in a respected journal
people
and doctors
obviously assume
that
the peer reviewers have anal have had
access to the data and they've
independently analyzed the data
and they corroborate the findings in the
manuscript that was submitted or they
give feedback to the authors and say we
disagree with you on this point and
would you please check our analysis and
if you agree with us making that's what
they assume the peer review process is
but it's not
the peer reviewers don't have the data
the peer reviewers have the manuscript
that's been submitted
by the
usually in conjunction with or by the
drug
company that manufactures the drug
so peer reviewers
are
unable to perform the job
that doctors think they're performing
to vet the data to assure that it's
accurate and reasonably complete
they can't do it
and then we have the clinical practice
guidelines which are increasingly more
important as
the information
the flow of information keeps getting
brisker and brisker and docs need to get
to the bottom line quickly clinical
practice guidelines become much more
important
and we assume
that the authors of those clinical
practice guidelines have independently
analyzed the data from the clinical
trials and make their recommendations
that set the standards of care based on
their analysis that's not what happens
the
experts who write the clinical trials
rely
almost entirely
on the
publications presenting the results of
the clinical trials which are peer
reviewed but the peer reviewers haven't
had access to the data so we've got a
system of the highest level of evidence
that doctors have been trained over and
over again to rely on to practice
evidence-based medicine to be good
doctors
that has not been verified do you think
that data
that's coming from the pharma companies
do you think they're uh
what level of manipulation is going on
with that data is it the at the study
design level
is it that literally there's some data
that you
just
keep off you know
keep out of the charts
keep out of the
the aggregate analysis then you then
publish
or
is it the worst case which is
just change some of the numbers
it happened all three happen i can't i
don't know what the denominator is but i
spent about
10 years in litigation
and for example in vioxx
which was withdrawn from the market in
2004 in the biggest drug recall in
american history
the problem was that
it got recalled when a study that merck
sponsored showed that vioxx doubled the
risk more than double the risk of heart
attacks strokes
and blood clots serious blood clots it
got pulled then but there was a study
that a bigger study that had been
published in 2000 in the new england
journal of medicine
that showed that vioxx was a better drug
for
um arthritis and pain
not because it was more effective it's
no more effective than aleve or advil
but because it was less likely to cause
serious gi complications bleeds and
perforations in the gut
now in that study that was published in
the new england journal
that was never corrected
it was a little bit
modified
15 months after the drug was taken off
the market but never corrected
merck left out three heart attacks
and the fda knew that merck left out
three heart attacks and the fda's
analysis of the of the data from that
study
said that they weren't gonna the fda
wasn't gonna do
the analysis without the three heart
attacks in it
and the important part of this story is
that there were 12 authors listed on
that study in the new england journal
two were merck employees they knew about
the three heart attacks that had been
omitted
the other
authors the academic authors
didn't know about it they hadn't seen
that data
so merck just
they had an excuse it's complicated and
the fda didn't accept it so there's no
reason to go into it
but merck just left out the three heart
attacks and the three heart attacks it
may seem 300 attacks in a 10 000 person
study may seem like nothing
except they completely changed the
statistics so that had the three heart
attacks been included the only
conclusion that merck could have made
was that vioxx significantly increased
the risk of heart attack
and they abbreviated their endpoint
from heart attacks strokes and blood
clots to just heart attacks yeah
so those are maybe in their mind they're
also playing by the rules because of
some technical excuse that you mentioned
that was rejected
how can this no because this is not let
me interrupt no that's not true
um
the study was completed the blind was
broken meaning they looked at the data
in march of 2000 the article was
published in the new england journal in
november of 2000. in march of 2000 there
was an email
by the head scientist
that was published in the wall street
journal
that said
the day that the data were unblinded
that it's a shame that the
cardiovascular events are there
but
the drug will do well
and we will do well
but removing the three heart attacks how
does that happen like uh
who has to convince themselves is this
pure malevolence
um
you have to be the judge of that but the
person who was in charge of the data
safety monitoring board
issued a letter that said they'll stop
counting cardiovascular events
a month before the trial is over
and they'll continue counting gi events
and that person got a contract to
consult with merck for five thousand
dollars a day i think for 12 days a year
for one or two years
that was signed that
contract
was signed within two weeks of the
decision
to stop counting heart attacks i won't
understand that man or woman i wanna
i want it's the uh i've been reading a
lot about nazi germany and and thinking
a lot about the good germans
because
i want to understand so that we can each
encourage each other to take the small
heroic actions that prevents that
because it feels to me
removing malevolence from the table
where it's just a pure psychopathic
person
that there's just no momentum
created by the game like you mentioned
yes
and so
it takes reversing the momentum
within the company
i think requires
many small acts of heroism not gigantic
i'm going to leave and become a
whistleblower and publish a book about
it
but small
quiet acts of pressuring against this
like what are we doing here we're trying
to help people is this the right thing
to do looking in the mirror constantly
asking is this the right thing to do
i mean that's how that's what integrity
is
acknowledging the pressures you're under
and then still be able to zoom out and
think what is the right thing to do here
but the data hiding the data
makes it too easy to live in ignorance
so like within those inside those
companies
so your idea
is that the reviewer should see the data
that's that's one step so to even push
back on that idea
is
i assume you mean that data remains
private except to the peer reviews
reviewers the problem of course is as
you probably know is the peer review
process is not perfect
you know it's individuals
it feels like there should be a lot more
eyes on the data than just the peer
reviewers yes
this is not a hard problem to solve when
a study is completed
um a clinical study report is made
and it's usually several thousand pages
and what it does is it takes the raw
patient data
and it tabulates it
in the ways
uh it's supposedly and usually
in the ways that the company has
pre-specified
so that you then end up with a
searchable let's say 3 000 page document
as
i became more experienced as an expert
in litigation
i could go through those documents
pretty quickly uh quickly may mean 20
hours or 40 hours but it doesn't mean
three months of my work
and
see if
the companies
if the way the company has analyzed the
data is consistent with the way with
their statistical analysis plan and
their uh pre-specified outcome measures
it's not hard and i think you're right
peer reviewers
i don't peer review clinical trials but
i peer review
other kinds of articles i have to do one
on the airplane on the way home and it's
hard i mean we're just ordinary mortal
people volunteering unpaid
the motivation is not clear
the motivation is to keep
um to be a good citizen
uh
in the medical community um and to be on
friendly terms with the journals so that
if you want to get published this sort
of an unspoken
yeah uh incentive
as a as somebody who enjoys game theory
i feel like that motivation is good but
could be a lot better
yes you should get more recognition or
in some way academic credit for it um it
should go to your career advancement if
it's an important paper and you
recognize it's an important paper as a
great peer reviewer that this is not
in that area where it's uh
uh like clearly piece of crap paper or
clearly an awesome paper that doesn't
have controversial aspects to it and
it's just a beautiful piece of work okay
those are easy
and then there is like the very
difficult gray area which may require
many many days of work on your part as a
peer reviewer so it's not you know it's
not just a couple hours but really
seriously reading like some papers can
take months to really understand
so if you really want to struggle um
there has to be an incentive for that
struggle yes and
billions of dollars
right on some of these studies
and lies
yeah right right not to mention right
but
it would be easy to have
full-time statisticians
hired by the journals or shared by the
journals
um
who were independent of any other
financial incentive
to go over these kind of methodological
issues
and take responsibility for the
for certifying the analyses that are
done and then pass it on to the
volunteer
uh peer reviewers see i believe in even
in this in the sort of capitalism or
even social capital
after watching twitter in the time of
covid
and just looking at people that
investigate themselves
i believe in the citizenry
people if you give them access to the
data like these like
citizen scientists arise a lot of them
on the it's kind of funny
a lot of people are just really used to
working with data
they don't know anything about medicine
and they don't have actually the biases
that a lot of doctors and medical and a
lot of the people that read these papers
they'll just go raw into the data and
look at it with
like they're bored almost and they do
incredible analysis so i i you know
there's some argument to be made for a
lot of this data to become public
like de-anonymized no sorry
anonymized all that kind of stuff but
for a lot of it to be public especially
when you're talking about things
um as impactful as some of these drugs
i agree 100 so let's turn the micro
let's get a little bit more granular
sure on the
peer review issue we're talking about
pre-publication transparencies
and that is critically important once a
paper is published the horses are out of
the barn and docs are going to read it
take it as evidence-based medicine the
economists call
what then happens as stickiness that the
docs hold on to their beliefs and i my
own
my own voice inside says once doctors
start doing things to their patients
bodies they're really not too
enthusiastic about hearing or was wrong
yeah that's the stickiness of human
nature wow so that that bar once it's
published
in
the doctors that's when the stickiness
emerges well yeah yeah it's hard to put
that toothpaste back in the tube now
that's pre-publication
transparency which is essential
and you could have
whoever saw that data pre-publication
could sign confidentiality agreements so
that the drug companies couldn't argue
that we're just opening the spigots of
our data and people can copy it and
blo all the excuses they make
you could argue that you didn't have to
but let's just let them do it let the
peer reviewers sign confidentiality
agreements and they won't leak the data
but then you have to go to post
publication transparency which is what
you were just getting at to
let the data free
and let citizens and citizen scientists
and other doctors who are interested
have at it
kind of like wiki wikipedia have at it
and
let it out and let people criticize each
other
okay so speaking of the data the fda
asked 55 years
to release pfizer vaccine data this is
also something i raised with uh albert
barola there's several things i didn't
like about what he said
uh so some things are expected and some
of it is just revealing the human being
which is what i'm interested in doing
but he said he wasn't aware of the 75
and the 55. i'm sorry women
he wasn't aware of the how long so here
i'll explain what
do you do you know that since you spoke
to him
pfizer has petitioned the judge to join
the suit on in behalf of the fda's
request
to
release that data over 55 or 75 years
pfizer's fully aware of what's going on
he's aware i'm i'm sure he's aware
in some formulation the exact years he
might have not been aware but but the
point is that there is
that is the fda the relationship with
faiza and the fda
in terms of me being able to read
human beings
was the thing he was most uncomfortable
with
that he didn't want to talk about the
fda
and that that relate it was clear that
there was a relationship there
that if
if the words you use may do a lot of
harm potentially because like you're
saying there might be lawsuits going on
there's litigation there's legal stuff
all that kind of stuff and then there's
a lot of games being played in this
space so
um i don't know how to interpret it uh
if he's actually aware or not but
the the deeper truth is
that he's deeply uncomfortable
um
bringing light to this part of the game
yes and
i'm going to read between the lines and
albert borla certainly didn't ask me to
speak for him
but
i think but when did you speak to him
how long ago wow time flies when you're
having fun uh two months ago two months
ago so
that was just recently it's come out uh
just in the past week it's come out
that
um
pfizer isn't battling the fda pfizer has
joined the fda
in the opposition to the request
to release these
uh these documents
in the same amount of time that the fda
took to evaluate them yeah so pfizer
is
offering
to help the fda
to
petition the judge
to not enforce
the timeline that he seems to be moving
towards so for people who are not
familiar we're talking about the freedom
of information act request
to release the pfizer vaccine data
study data
to release as much of the data as
possible like the raw data the details
or so actually not even the raw data
it's
data
doesn't matter there's details to it and
i think the response from the fda is
that
of course yes of course
uh
but uh you know we can only publish like
some x number of pages a day
500 pages 500 pages of data it's not a
day though it's uh whatever a week i
think the point is whatever they're able
to publish is ridiculous it's like um
my printer can only print three pages a
day
and we cannot afford a second printer so
it's it's some kind of bureaucratic
language for you know there's a process
to this
i you know and now you're saying that
pfizer is obviously um
more engaged in helping this kind of
bureaucratic process
prosper in its full absurdity
kafka-esque absurdity so
what is this this really bothered people
this really this is really troublesome
and just to put it in
just plain english terms
pfizer's making the case that it can't
the fda and pfizer together are making
the case that they can't go through the
documents
it's going to take them some
number 100 fold hundreds of folds more
time to go through the documents than
the fda required to go through the
documents to approve
the vaccines to give the vaccines full
fda approval and the fda's argument talk
about kafka-esque
is that to do it more rapidly would cost
them three million dollars
three million dollars
equals one hour of vaccine sales over
two years
one hour of sales
and they can't come up with the money
and now pfizer has joined the suit to
help the fda fight off this judge this
mean judge who thinks they ought to
release the data but evidently pfizer
isn't offering to come up with the three
million dollars either so bought for
three million i mean maybe
the
maybe the fda should do a gofundme
thing
well obviously the money thing
[Music]
i mean i'm sure if elon musk comes along
and says i'll give you 100 million
publish it now
i think they'll come up with another
so i mean that there it's clear that
there is um
cautiousness i don't know the source of
it
from the fda there's only one
explanation that i can think of
which is that the fda and pfizer don't
want to release the data
they don't want to release the
three or five hundred thousand pages of
of uh documents
and i don't know what's in there i'm i
want to say one thing very clearly
i am not an anti-faxer i believe the
vaccines work i believe everybody should
get vaccinated uh the evidence is clear
that if you're vaccinated you reduce
your risk of dying of covid by 20-fold
and we've got new sub-variants coming
along and i just want to be very clear
about this
that said
there's something i would
give you ten to one odds on a bet that
there's something in that data
that um is going to be embarrassing to
either fda or pfizer or both so there's
two options i agree with you 100
one is they know of embarrassing things
that's option one
and option two
they haven't invested enough to truly
understand the data
like to i mean it's a lot of data
that they they have a sense there might
be something embarrassing in there and
if we release it
surely the world will discover the
embarrassing end
uh to do uh sort of the steel man their
argument they'll take the small the
press
the people will take the small
embarrassing things and blow them up
into big things yes and support the
anti-vaxx yes campaign yes i think
that's all possible
nonetheless the data are about the
original clinical trial and
the emergency youth's authorization was
based on the first few months of the
data from that trial and it was a
two-year trial the rest of that data has
not been opened up and there was not an
advisory committee meeting
to look at that data when the fda
granted full authorization again i am
pro-vaccine i am not making an
anti-facts
argument here but
i suspect that there's something pretty
serious in that data
and the reason why i'm not an anti-faxer
having not been able to see the data
that the fda and pfizer seemed to
willing not just to put effort into
preventing the release of but seem to
have quite a bit of energy into
preventing invest
quite a bit of energy in not releasing
that data the reason why that doesn't
tip me over into the anti-vaxxer side is
because that's clinical trial data early
clinical trial data that involved
several thousand people we now have
millions of data points from people who
have had the vaccine this is real world
data
showing the efficacy of the vaccines and
so far knock on wood there aren't um
side effects that overcome the benefits
of vaccine
so i'm i'm with you i'm now
i guess three shots
of the vaccine
but there's a lot of people that are
kind of saying well even the data on the
real the real world use large-scale data
has um
has is messy
the way it's being reported the way it's
being interpreted
well one thing is clear to me
that it is being politicized it's i mean
if you just look objectively
don't
have to go to at the shallow surface
level
it seems like there's two groups
that
i can't even put a term to it uh because
it's not really pro-vaccine versus
anti-vaccine because
it's it's it's pro
vaccine triple mask
democrat
liberal
and then anti-mandate
whatever whatever those groups are i
can't quite cause they're changing
but not really but kind of so those two
groups that feel political and nature
not scientific in nature it's they're
bickering and then
it's clear that this data is being
int